Manager, Quality Resume Samples

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IV
I VonRueden
Ibrahim
VonRueden
3779 Melisa Shoal
Houston
TX
+1 (555) 683 3367
3779 Melisa Shoal
Houston
TX
Phone
p +1 (555) 683 3367
Experience Experience
San Francisco, CA
Assistant Manager Quality
San Francisco, CA
Tromp, Vandervort and Reichel
San Francisco, CA
Assistant Manager Quality
  • Monitor performance of the process by gathering relevant data and producing statistical reports
  • 13 Perform other job-related duties as assigned
  • Take lead in setting up SLA , KPI’s , work with Operations and Customers to define measurements
  • 12 Lead investigations and deviations to determine root cause, correction/preventative actions and effectiveness checks. Monitor CAPA’s and effectiveness checks to ensure issues are resolved
  • Provide guidance, direction and evaluation of work of the associates, provide regular feedback on staff performance
  • Provide data and interpretation of measurements and audits, written communication and oral presentation
  • 5 Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies
Los Angeles, CA
Manager Quality
Los Angeles, CA
Rau, Block and Rice
Los Angeles, CA
Manager Quality
  • Providing leadership and direction to Quality Assurance Supervisors and support teams while embodying the principles of the Genzyme Global Leadership Model
  • Ensuring timely issue escalation to Quality Assurance senior management and cross-functional support teams
  • Effective interaction with other departments on matters related to investigation and finished drug product disposition. In particular Quality Control, Manufacturing, Planning, Regulatory Affairs and Manufacturing Technical Support
  • Working with recruiters to maintain staffing levels and meet approved hiring plans, conducting performance appraisals and career development assessments for all direct reports
  • Leading in scheduling, MDI, project, and staff meetings, providing updates of department activities and project statuses to senior management
  • Food Safety & Quality
  • Develop and maintain the local Quality Management System
present
Boston, MA
Manager, Quality
Boston, MA
Bahringer, Leffler and Hartmann
present
Boston, MA
Manager, Quality
present
  • Work cross-functionally with all other business unit functions by maintaining productive working relationships and promoting QA involvement
  • Assists in defining and establishing ongoing performance measures for centre personnel
  • Drives continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams
  • A saving in material, labour and utilities of $XXMM /year via identifying losses and waste & rectifying them
  • Deploy the Advanced Quality Planning (AQP) deployment for internal manufacturing activities as well as for suppliers
  • Deliver continuous improvement through innovation, benchmarking, sanitation effectiveness and efficiency evaluations and leveraging cross-BU collaboration
  • Coordinating and following up with client to ensure progress as per the agreed scope and overall project schedule
Education Education
Bachelor’s Degree in Engineering
Bachelor’s Degree in Engineering
Florida International University
Bachelor’s Degree in Engineering
Skills Skills
  • Working knowledge of applicable customer contact systems, monitoring systems, and reporting software / applications
  • Knowledge of Clinical Processes/Core Measure indicators; internal and external database proficiency
  • Strong organizational skills through demonstrated ability to multi-task and manage time
  • Proficiency in MS PowerPoint, Excel, Word, and database applications
  • Excellent oral and written communications
  • Strong project management and problem solving abilities
  • Ability to supervise and motivate employees
  • Excellent interpersonal and communications skills at all levels
  • Demonstrated ability to handle multiple tasks and assignments simultaneously
  • Strong interpersonal skills / Performance-oriented
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15 Manager, Quality resume templates

1

Manager, Quality Resume Examples & Samples

  • Supports Director Quality FW (LO) and Manager QIP to establish with Footwear Quality and Senior Director Sourcing FW a quality evaluation system that is linked with the footwear sourcing SCP
  • Conducts and manages quality system audits and random finished goods inspection at T1 suppliers
  • Leads & manages quality integration program (QIP) within the region
  • Leads and manages all quality related themes in development, commercialization and production
  • In collaboration with Manager Quality QIP and Director Quality FW (LO), audits & rates T1 QIP set up and implementation status
  • Guides implementation of QIP systems at new T1 facilities
  • Conducts random finished goods inspection at T1 factories and consolidation warehouses
  • In collaboration with Director Manufacturing, certifies T1 QIP final inspectors
  • Manages implementation of 3rd party finished goods inspections at T1 suppliers
  • Trains and manages training related to QIP at LO, T1 & T2
  • Establishes and implements QIP, QATs and QA plans in development & commercialization phase in collaboration with LO Senior Management
  • Athletic Footwear manufacturing and development experience of advantage
  • IT-skills (e-mail, MS Office)
  • Bachelor’s degree and / or at least 3-5 years of relevant business experience
  • Degree in Quality Management and / or extensive manufacturing experience
2

Assistant Manager Quality Resume Examples & Samples

  • Supervise QA staff in carrying out process audits and measurements on timely basis
  • Take lead in setting up SLA , KPI’s , work with Operations and Customers to define measurements
  • Independently conduct process audits on assigned processes
  • Perform as a trainer to QA team on Quality tools & Techniques
  • Provide data and interpretation of measurements and audits, written communication and oral presentation
  • Identify opportunities to share/adopt process standardization and best practices across GSS centers
  • Organize and manage quality assurance function in close co-operation with the customers and with the leadership
  • Provide guidance, direction and evaluation of work of the associates, provide regular feedback on staff performance
  • Provide opportunity to staff and develop self and team members
  • Contribute ideas/opinions to the team and listen/respond to other team members' views
  • Use technology to continually learn, share knowledge with team members, and enhance service delivery
  • Trained in quality management and compliance standards and methodologies, Six Sigma, LEAN, trained in advanced
  • Preferably have expertise in transaction processing and reporting processes
  • Drive and deliver the agreed initiative/project
  • Be able to work in a rapidly changing environment
  • A strong team player who is comfortable working collaboratively and directionally as required
3

Policy Manager Quality Review Resume Examples & Samples

  • Evaluate and monitor QM standards, processes, and reports for appropriateness and adherence to contract requirements, accreditation standards, and industry best practices
  • Identify operational barriers/issues, facilitate their resolution, and identify opportunities for improvement
  • Research relevant literature, develop, implement, evaluate, and analyze clinical data, programs, tools, and reports to identify opportunities to improve care and clinical outcomes
  • Develop policy and procedures as needed related to CQM process and activities
  • Communicate and collaborate effectively with internal and external customers; including reporting and presentations
  • Explore initiatives for beneficiary and provider education to advocate patient safety and promote health and wellness
  • RN with 2-4 years clinical experience
  • BSN or similar degree in other health care related field
  • Basic Computer skills (Word, Windows, Excel)
  • 3 years quality management experience
  • 3 years in a managed care environment
  • 2 years management experience
  • Advanced computer skills (Access)
  • Certification in Qualtiy or Managed Care
  • Analytical and experience with Data Analytics
4

Manager, Quality Resume Examples & Samples

  • 3) Develops audit checklists, perform and coordinate internal and external audits, manages corrective action program including effectivity of corrective actions taken
  • 4) Assists in establishing plant-wide quality policies, systems, procedures and upgrading the quality system to comply with ISO/AS, FAA and other customer’s requirements
  • 5) Publish Quality Metrics as required
  • 6) Supports technical coordination meetings with suppliers and customers concerning quality issues
  • 7) Reviews and approves purchase orders to ensure that Quality, Engineering and customer’s requirements have been passed on to suppliers
  • 8) Informs management of all abnormal conditions. Provides information to improve quality procedures
  • 9) Day to day support, interface directly with employees and manage Document Management, Test lab, QMS compliance and other activities as assigned to you
  • 10) Assist in transition from Development to Production (NPI, TTP, etc.)
  • General Management
5

Manager, Quality Resume Examples & Samples

  • Review operations, project assignments and delegation, perform reviews, and continually train and implement quality control
  • Be the primary Private Markets editorial contact in the U.S. for internal Dow Jones groups including News, Product, Technology, Automation/Reporting, Customer Service and Sales
  • Be a secondary Private Markets editorial contact for content vendors and other external suppliers
6

Manager Quality Accessory & Gear Resume Examples & Samples

  • Collaborates with respective LO teams and factories to drive implementation of global quality programs, certifications and best practices, as well as conducts quality audits with the aim of continuously improving overall quality
  • Work closely with LO Production Managers in driving together quality mindset in the LO team and the respective factories; instilling the right quality lens in the factories
  • Collaborates with the Manufacturing Excellence team in order to achieve the quality module part of the ME toolbox
  • Be the quality expert and coach, provides answers/guidance for quality related issues during development and production stage
  • Collaborates with respective teams in timely resolving quality issues in production and development areas according to adidas Group standards in order to achieve quality and delivery objectives, and drive improvement results
  • Frequently visit the factories to be in direct contact with the products and identify potential quality risks
  • Understands product manufacturing processes in order to analyze risk factors using statistical data’s to prevent from quality problems
  • Collaborates with production team in analyzing product returns and provide correctives and consistent solutions
  • Ensure all quality related standards, manuals, guidelines and reports are up to date
  • Strong managerial and communication skills
  • Able to coach T1 and LO team to provide the right quality guidance
  • Competency in ISO process, Lean Six Sigma, Total Quality Management or other quality management system
  • Good MS-Office, Outlook skills
  • Minimum 3 years’ experience in manufacturing, technology or quality assurance
  • Bachelor degree in Engineering, Technical or equivalent related technical experience
7

Manager, Quality Resume Examples & Samples

  • Bachelor’s degree in engineering, , technical engineering or science discipline
  • 10+ years of operations/manufacturing experience
  • 5+ years management experience in a manufacturing/supplier quality environment
  • Lean and Six Sigma experience
  • An innovative and dynamic individual
  • Good writing & speaking in English, mastery in Mandarin
  • Strong leadership experience and skills
  • Lean and Six Sigma experience and experience with Minitab software a plus
  • Management experience and the proven ability to work in a matrix organization required
  • Thorough knowledge of quality methods and systems is required (statistics, reliability, sampling and auditing)
  • ISO/TS quality system working knowledge and auditing experience preferred
  • An experienced background in various types of manufacturing
  • Specific knowledge in the plastics, metals, wood, or electric commodities is preferred
  • Strong project management and problem solving abilities
  • Demonstrated ability to handle multiple tasks and assignments simultaneously
8

Manager, Quality Resume Examples & Samples

  • Prepare Quality Assurance Plan and Documents for implementation in the project
  • Prepare Quality Control Procedures to be applied by the Project Management Team
  • Work in close coordination with various technical teams of GC and assist them in implementing the Quality Assurance Systems
  • Review the bid documents submitted by tenderers for the civil packages focusing on aspects related to implementation of quality assurance/quality control system
  • Review the Quality Assurance Management Systems of the Project Contractors including their Plans & Procedures to ensure that a robust Quality Control/Assurance regime is brought in force on the Project
  • Perform scheduled and random Quality audits of the contractors' works at site and issue NCR for non-conformance
  • Work with contractors and drive to achieve the Quality objectives for the project
  • Contribute in preparation/finalization of relevant Quality Assurance Manual
  • Any other task or responsibility which is stated or intended as per TOR contained in RFP for GC services
  • Ensuring compliance with quality assurance requirements and compliance of ISO Documentation/Reports
  • Responsible for day-to-day activities, reports, budgeting and optimal capacity utilization of resources
  • Coordinating and following up with client to ensure progress as per the agreed scope and overall project schedule
  • Should have worked in General Engineering Consultancy work for Metro Rail system
  • Familiar with local code and authority submission procedure
9

Manager, Quality Resume Examples & Samples

  • Manages the activities of several sections or departments in the Quality organization with responsibility for results in terms of product quality
  • Implements the quality systems procedures in several sections or departments and manages compliance
  • Understands and assures conformance to regulations applicable to several sections or departments. Interfaces with regulators during inspections
  • May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk
  • Interacts frequently with internal subordinate supervisors, functional peer and senior group managers
  • Manages interactions with regulators and customers to represent the company products and processes
  • Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
  • Develops budget for several sections or departments and ensures adherence to the budget
  • Manages coaching, training and development of subordinates
  • Strong interpersonal/communication/influencing/negotiation skills
  • BS in science or engineering; advanced degree helpful
  • 7 years in Quality, Manufacturing, Engineering or related field
10

Manager, Quality Advice Resume Examples & Samples

  • Experience in a leadership role with significant (demonstrable) experience in leading and developing a collaborative multi location high performing team
  • Demonstrated experience in driving continuous improvement in team performance utilising workflow management and productivity tools highly regarded
  • Track record and ability in managing complex internal relationships, including engagement with Licensees and Adviser board groups
  • Strong financial planning / compliance skills highly regarded
11

Manager, Quality Resume Examples & Samples

  • Develops and maintains a quality plan for service center operations; including service quality standards; quality scorecards; monitoring; coaching; performance metric assessment; and improvement actions
  • Manages a team of Quality Assurance Monitors and/or Specialists by establishing roles; work standards; performance objectives; and enforcement through regular oversight
  • Monitors and reports service center performance against service level agreements and performance standards; initiating improvement actions when opportunities are identified
  • Analyzes performance trends and takes proactive steps to prevent service shortcomings
  • Reports performance information through formal and informal reports that may be contractual deliverables
  • Represents the quality function to clients; serving as a point of contact for quality inquiries
  • 8-10 years of related experience in call center monitoring; quality assurance; and/or customer service
12

Manager Quality Resume Examples & Samples

  • Bachelor’s Degree in Sciences and 7 years in CGMP manufacturing environment
  • Training, coaching, leadership experience
  • Experienced leading Quality teams to maintain adherence to a demanding production schedule
  • Experienced facilitating meetings
  • Experienced authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents
  • Experienced in product disposition
  • Experienced in external and leading internal audits
  • Experienced leading cross-functional teams, including Quality, Manufacturing Technical Support, Facilities and Engineering and Validation
  • Experienced in making strategic decisions on safety, process, scheduling and personnel- related issues
  • Ability to effectively and appropriately make decisions on complex Quality issues
  • MS Office, ERP, Trackwise, LMS
  • Experienced leading and delivering the implementation of improvements to technical and business processes
13

Manager, Quality Resume Examples & Samples

  • Lead assessments of the quality Systems for compliance (ex: customers, FDA, and ISO Registrars). Ensure such assessments are conducted in accordance with established policies and procedures. Define actions required to maintain the compliance of the Quality System according to company and regulatory requirements
  • Define, develop, and implement quality and compliance training programs that provide the necessary skills and knowledge needed by Commercial Operations personnel to achieve company and regulatory objectives including compliance
  • Direct employees on quality/ regulatory elements and process improvements. Encouraged staff to take initiate, to be proactive, and to strive to improve their work and the processes that shape their work
  • Determine appropriate KPIs and benchmark levels for key quality indicators
  • Assist the function areas in identifying the appropriate actions and opportunities to meet and exceed objectives. Lead or facilitate teams to accomplish these deliverables, milestones, and objectives
  • 6 Write and revise operative procedures and process documents where necessary. Ensure that written procedures are maintained to define the specifications an procedural requirements affecting product quality and that effective change controls are maintained to assure that any changes are thoroughly reviewed and shown to be appropriate, including review for their potential to affect validations and regulatory submissions
  • Mange the CAPA process for US Commercial Operations. Ensure training, procedures and metrics are in place to meeting global objectives for on time CAPAs
  • Mange the Field Actions process for the US. Ensure training, procedures and metrics are in place to meet global objectives for Field Action completion
  • Lead the Internal, Supplier, and Distribution Audit programs for US Commercial Operations. Ensure audits are conducted in accordance with the schedule. Lead audits in developing and implementing corrective actions arising from the audit findings
  • Establish, maintain and improve reports of quality data such as the quality scorecard and business dashboard to assist in the continuous improvement of quality and business maturity. This data is to be included in monthly reports to senior executives and the QSMR
  • Develop and manage junior members of the Commercial Operations QA/RC team. Ensure they receive training necessary to complete their responsibilities, advance their skill set and provide an opportunity for advancement
14

Manager Quality Eng Resume Examples & Samples

  • Line management responsibilities for a team of 16 QAs including automated test specialist and performance testers
  • Ownership and oervall responsibility for the full quality process and strategy
  • Coach, mentor and help up-skill QA team members
  • Work with the Director of Engineering and other Program Team members to drive overall project process and strategy to meet business needs and technical best practice
  • Provide appropriate reporting on the effectiveness if the quality assurance effort
  • Help to grow the London teams by assisting with the recruitment of other team members
  • Work with the Head of Development to help to guide the overall development process in order to improve quality and flow of work
  • Extensive experience in managing, inspiring and motivating QA teams with a broad range and level of skills and experiences
  • Experience in setting up and defining test strategies and processes
  • Experience with a collaborative BDD approach to automated testing
  • Agile experience with Scrum / Kanban / XP
  • A positive, constructive and pragmatic approach with an emphasis on collaboration and good execution
  • Experience in hands on coaching / mentoring of junior team members
  • Experience using test / project management / wiki tools such as JIRA / Confluence
15

Manager, Quality Resume Examples & Samples

  • 50% --
  • Develop the team to be effective and meet performance objectives
  • Implement Newell Brands Quality policies and procedures
  • Perform Production Part Approval Process (PPAP) following the Quality Network Process. Manage PPAP completion from beginning to end to meet program goals
  • Perform Process Control Audits
  • Lead Reactive Problem Solving Initiatives
  • Prepare and manage Supplier Quality Metrics
  • Lead Lean/OPEX and Six Sigma initiatives with identified suppliers
  • 20% --
  • Work collaboratively with customer service regarding consumer/customer complaints
  • Lead internal teams to investigate and resolve customer/consumer complaints
  • Work with suppliers to resolve defective material issues, using root cause analysis and corrective and preventive actions (CAPA)
  • Work with suppliers to achieve continuous quality improvement
  • 10% --
  • Work collaboratively with other segment and functions as needed
16

Manager Quality Resume Examples & Samples

  • Current Florida RN license
  • CPHQ certification within one year of hire
  • 3-5 years’ experience focusing on Quality Management and performance improvement
  • Minimum of one year Hospital experience preferred
  • Auditing experience preferred
  • Thorough knowledge of quality management practices, core measures, hospital policies and procedures and regulatory requirements
17

Manager, Quality Resume Examples & Samples

  • Manages, supervises and provides direction to quality personnel on professional, personnel issues, and career development opportunities
  • Provides direction to personnel on topics such as complaint reporting, FDA requests for additional information, field action assessment and execution, electronic complaint management system implementation and validation, and other quality elements for Neurovascular
  • Identifies the opportunities for continuous improvement of quality systems impacting post market surveillance, design controls, CAPA, field actions, internal audits and initiates activities to support the improvement activities
  • Routinely presents data, analyses, and recommendations to partners at the business to ensure compliance and customer satisfaction
  • Represents the post management process to national regulatory agencies, during audits, to demonstrate compliance
  • Strategizes with department leaders to develop long term vision, objectives and goals for the organization
18

Manager, Quality Resume Examples & Samples

  • Drive performance through management and analysis of Quality data, process/procedures and their impact on KPIs, customer satisfaction and goals of the GCO OPN organization
  • Maintain a solid understanding of business practices and strategic direction across multiple Partners (both banking and NEXUS), and their respective vendor contact centers with an ability to quickly grasp and articulate the implications of system, process, and delivery issues and trends
  • Monitor the performance of the Quality Program and related activities on a continuing basis, proactively identifying areas of opportunity and taking appropriate steps to improve its effectiveness
  • Instill rigor and discipline around policy, procedure and process change management to enhance agent performance and remove roadblocks to agent success
  • Provide operational support, calibrations, regular Quality performance reviews and other contractual tasks specific to each Partner as required
  • Identify opportunities for improvements and influence change that results in the reduction of non-value-add activities within Operations
  • Liaise with multiple internal and external business units, Partners, Service Delivery, Learning & Development and Center leadership teams to develop and implement corrective action plans for resolution of problematic business and performance issues, providing guidance and ensuring future opportunity areas are diagnosed and acted upon
  • Implement globally consistent best practice strategies that fit our scale and operational model
  • Strong analytical and communication skills required. Project Management skills a plus
  • Can turn innovative ideas into reality and know and show how to replicate successes in scale across multiple brands, markets, languages and cultures
  • Ability to interface at multiple levels throughout the organization to drive results
  • Recognizes problems, systematically gathers information, sorts through various levels of complexity, seeks input from others, and addresses root cause
  • Ability to elicit cooperation from a wide variety of sources, including leadership, partners, and other departments
  • Experience in cultivation and maintenance of strong working relationships and collaboration across multiple business, delivery and technical teams
  • Ability and willingness to travel and adopt flexible working hours to suit business and geographical scale of the role
  • Bachelor’s degree required / Master’s degree preferred
  • Proven data analysis skills with 3-5 years’ experience in analytics or similar function
  • 5+ years of experience in a highly analytical, results-driven environment. Previous Quality Management in an outsourced/vendor environment highly desirable
  • Proven ability to manage to deadlines while working in a fast paced, evolving, team environment
  • Experience with customer-focused organizations that operate globally
  • Have experience working through complex business problems and partnering with internal and external clients using a consultative approach
19

Manager Quality Issues Resume Examples & Samples

  • Provides consultation to project teams and functions on complex GCP questions
  • Participates in Trusted Process meetings where complex quality issues are discussed
  • Tracks questions and answers to document frequently asked questions (FAQs) and proposes strategies for improvement of quality and compliance based on the FAQs
  • Reviews a subset of the “critical” reported Quality Issues. Ensures that the information entered by the reporters is of high quality, includes the problem statement, the root cause of the Quality Issue, the corrective actions, and the preventive actions
  • Escalates Quality Issues in line with regulatory requirements (e.g. Serious Breaches)
  • Maintains information about Quality Issues in an up-to-date manner to allow for timely analysis
  • Proposes strategies to Senior Quality Management for improvement of Quality Issue Management
  • Line management responsibilities for staff members: May participate in and manage activities such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. May approve courses of action on salary administration, hiring, corrective action, and terminations. May review and approve time records,expense reports, requests for leave, and overtime
20

Manager, Quality Issues Resume Examples & Samples

  • BA/BS degree in science or health care field or equivalent combined education and experience
  • Extensive experience in similar positions within clinical research environment
  • Leadership skills preferred
  • Ability to act independently and pro-actively, above average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills, and communication skills
21

Manager Quality Resume Examples & Samples

  • General Quality Management: manages the quality of manufacturing processes, materials, equipment, and end-products. May establish quality/inspection methods, standards, and procedures. Responsible for the corrective action systems activities ensuring actions are implemented to prevent reoccurrence. May manage defined elements of the Quality System. Manages the overall preparation, revision and control of all documentation in compliance with regulations and guidelines
  • Quality Assurance Management: develops, maintains and ensures compliance with quality programs, policies, processes, procedures and ensures that the performance and quality of products conform to established standards, specifications and agency guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations and agency guidelines to assure compliance. Works directly with operating entities to ensure that inspections, process control analyses or audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. Ensures the quality assurance programs and policies are maintained and modified regularly. Establishes and ensures that inspections are conducted prior to the processing of raw materials, ingredients, product and package specifications, frequently at vendor/supplier locations. May serve as liaison between the company and various governmental agencies
  • Quality Control Management: develops, implements and maintains technical quality assurance and control systems and activities. Defines and specifies the implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Participates in the reviewing of engineering designs to contribute quality requirements and considerations. Assists product support areas in gathering and analyzing data
  • Regulatory Compliance Management: manages the reporting, corrections and removals or customer communications processes. Responsible for the continuous improvement within the department. Manages the overall preparation and internal communications of all FDA compliance related activities
  • Complaint Handling Management:: oversees the development of strategies, systems, processes and staff to ensure fully compliant and timely handling of returned products associated with customer complaints. Responsible for overseeing the development and maintenance of formal investigation guides and systems that allow for comprehensive analysis of all phone solved and returned product complaints along with their respective investigation results. Also responsible for assembling and delivering presentation to the Global Safety Board should instances of critical complaints be confirmed. Ultimately responsible for serving as an impetus for product and process improvements by communicating results of complaint trending/investigations and influencing the respective parties that are chartered to effect improvements in the design of processes/products
  • Assist the Director or senior leadership in overall operations of assigned department(s). Contributes and achieves results through the management of subordinates (professional and support staff). Establishes and manages the department's budget and all assigned resources. Provides leadership to ensure department objectives and goals are achieved. Directs and implements tactical plans. Has full discretion on all employment decisions for department staff including hiring, training, performance management, and progressive disciplinary actions
  • Ensures the RDCI Quality Policy is understood, implemented and maintained in the organization. Establishes and maintains an adequate organizational structure, provides adequate resources and establishes appropriate management controls to ensure their group is suitable and effective to satisfy regulatory requirements and the company’s quality policy and objectives. Performs the quality planning to drive continuous improvements and changes of the RDC quality system to ensure ongoing effectiveness and efficiency. Develops and drives a work culture committed to compliance, quality and customer focus
22

Manager Quality Resume Examples & Samples

  • QUALITY
  • Develop and maintain the local Quality Management System
  • Prepare and organize local management reviews
  • Coordinate and conduct internal quality and compliance audits for both Saudi & the Middle-East
  • Monitor defined key performance indicators
  • Drive the corrective and preventive action process
  • Act as international customer complaint analyst
  • Perform quality training in the organization with a focus on Training and Awareness of the compliance and quality policies at the “on boarding” of new hires
  • Ensure the integration of quality practices and Company procedures into the local processes
  • Responsible for the local quality documentation
  • Technical / life science background
  • Previous experience in Quality / use of Quality tools
  • Knowledge of ISO 9001 / 13485
  • Good communication skills and very good command of English language – spoken, written
  • Analytical, problem solving oriented, detail oriented
  • Ability to manage independently processes and tasks
  • Adaptability to work under time pressure
  • Proven ability influence without authorityA good knowledge of business processes is required, particularly in IVD commercial activities, Distributors and Quality processes
  • Ability to work closely with cross functional departments mainly operations and commercial across multiple geographies
23

Manager Quality Resume Examples & Samples

  • Drives implementation of QIP systems at new T1 facilities
  • Conducts QIP and BA trainings based on identified needs of T1 QIP/BA final inspectors as well as 3rd Party AQL inspectors
  • Certifies AQL, FINAL, BA and 3rd party inspectors together with Senior Manager Quality
  • Supports Senior Manager Quality at new roll-outs related to CTNQ at LO, T1 & T2
  • Advanced knowledge of shoe making and Footwear manufacturing
  • Management skills
  • Strong interpersonal and communication skills to be able to interact with different levels of business
24

Manager, Quality Resume Examples & Samples

  • Bachelor's degree in Computer Science, Computer Engineering or equivalent combination of technical education and experience
  • 8+ years of overall QA experience, knowledge of QA methodology and tools, software testing standards, methods and conventions, and the product development cycle
  • Strong people management skills with a proven track record in hiring, developing and retaining high performing QA team consisting of QAEs and SDETs
  • Strong QA background with experience in identifying and reviewing test plans, test cases and testing results
  • Proven track record in identifying and implementing automated testing tools and frameworks
  • Strong project management skills, preferably with experience in an agile development environment
  • Excellent quality and release management skills
  • Experience working with geographically distributed QA, business and development teams
  • Solid track record for delivery of high quality products
  • Experience in preparing quality metrics and effectively engaging with stake holders to set and drive quality goals
  • Experience shipping 3+ products (guiding them through a full QA process)
  • Experience working in an Agile and test-driven development environment
  • Experience driving continuous integration models into code teams
  • Ability to track multiple test efforts simultaneously and report results
  • Creativity and initiative to continually improve test coverage and effectiveness
  • Excellent written and verbal communication skills, with a track record of working effectively with Development Engineering and other functions
  • Fluency in programmatic-level testing and user-level automation is a plus
  • Superior communication and analytical skills, including strong ability to identify and solve ambiguous problems
25

Manager Quality Enterprise Systems Resume Examples & Samples

  • Participates and assists in the development of IT strategy and roadmaps for the Quality Management areas in collaboration with business and IT peers
  • Works closely with the Operations and IT organizations to develop standardized global business processes
  • Leads and influences the analysis of quality management information systems in project areas such as available product functionality, new business processes & operating models, and operational readiness assessment
  • Acts as the business project lead cross-functional implementation teams that are responsible for the configuration, testing, validation and training of quality management system solutions along with system deployment activities across all worldwide sites
  • Helps to ensure high quality URS is defined for each system and each system is designed and built to meet all applicable GxP, legal, and fiduciary policies, practices and requirements
  • Responsible for coordinating the delivery of project communications, organizational change management activities and the quality of all project deliverables
  • Ensures that processes are developed and implemented to effectively transition post-implementation support activities to the QES Support Team
  • Coordinates the ongoing system support (w/ the various IT technical areas) and the global change management and change control of existing systems
  • Application steward acting as the global business representative when assessing new technology solutions or enhancements to existing solutions, in order to improve the capabilities and influence the direction of technology platforms
  • Bachelor’s Degree in Computer Science, Business Administration, or other Science related field
  • 5+ years’ experience in supporting Quality IT projects and teams in a global environment
  • 3+ years of leadership responsibility managing cross functional teams and influencing senior-level management and key stakeholders
  • 3+ years’ experience in supporting the implementation of either (e.g., TrackWise) EQMS or (ComplianceWire) LMS and (e.g., Documentum) EDMS, in a global environment
  • Pharmaceutical and/or life sciences experience including Computer System Validation, 21 CFR Part 11 and general GxP Quality Management experience preferred
  • Strong team player and independent contributor with solid strategic thinking, creativity and analytical skills
  • Travel of approximately 25%
26

Manager Quality Enterprise Systems Resume Examples & Samples

  • Participates and assists in the development of IT strategy and roadmaps for the Quality and Lab areas in collaboration with business and IT peers
  • Leads and influences the analysis of lab information systems in project areas such as available product functionality, new business processes & operating models, and operational readiness assessment
  • Acts as the business project lead cross-functional implementation teams that are responsible for the configuration, testing, validation and training of lab system solutions along with system deployment activities across all worldwide sites
  • 3+ years’ experience in supporting the implementation of either (e.g., LabVantage) LIMS and (e.g., Empower, OpenLAB) Chromatography solutions, in a global environment
27

Manager Quality Resume Examples & Samples

  • Select, develop, and motivate qualified staff to effectively carry out department functions and
  • Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance
  • Coach and mentor staff in all aspects oftheir job performance and career development including training, feedback, rewards and disciplinary action
  • Develop work plans, assign tasks, and supervise team(s)
  • Ensure staff has appropriate knowledge of department processes and procedures
  • Ensure timely review of documents to support product disposition
  • Ensure timely issue escalation to Quality Assurance senior management and cross-functional support teams
  • Demonstrated report writing capabilities
  • Experience facilitating meetings
  • Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents
  • Experience of using operational excellence tools to drive continuous improvement
28

Manager Quality Resume Examples & Samples

  • 10% - 30% travel required (domestic and international)
  • Shanin Structured problem solving
  • Shainin Journeyman certification by the Shainin organization
  • Quality tools including 8D, 3 Legged 5 Why, Fishbone, Pareto
  • PPAP process
  • Flow Chart, PFMEA, Control Plan, MSA, GR&R
29

Manager Quality Resume Examples & Samples

  • Develops, implements, and manages the program-specific quality, environmental health and safety initiatives
  • Manages the Program quality and safety plan as described in contract and task orders. Incorporates customer requirements in all process improvement activities
  • Responsible for Program deliverables as bid
  • Serves as Program Leader for quality and safety
  • Coordinates the implementation at the program sites to ensure corporate-sponsored best practices for quality assurance processes are implemented and followed
  • Works collaboratively with Program Leadership to develop, implement and sustain continual process improvement programs, including Lean Six Sigma initiatives
  • Reviews the achievements and action plans of Program Site Process Action Teams (PATs)
  • Accountable for on time delivery of high quality improvement projects within the Program
  • Acts as the Program’s change agent
  • Works with internal customers, external customers and program leadership as needed to meet goals and communicate performance to the Program Leadership
  • Reviews Program Site reports to ensure environmental health and safety programs conform to established standards, applicable regulatory requirements, and customer specifications, thereby achieving high customer satisfaction levels
  • Reviews and ensures DI and host nation health and safety regulations
  • Reviews incident investigations, root cause analysis and closure of corrective actions
  • Promotes health and safety awareness
  • Coaches and Coordinates the development and implementation of program-specific process improvement initiatives including Lean Six Sigma, CMMI and safety and health initiatives
  • Conduct audits, inspections to ensure compliance with DI policies and procedures and implement corrective actions as required
  • May serve as liaison between for the Programs to various governmental agencies inside or outside the United States
  • Develops, collects and reports performance metrics as needed at the PMO Level
  • Participates in the identification and implementation of all continuous process improvement activities
  • Lean Six Sigma Green or Black Belt with in-depth practical application of Lean maintenance service line methodology
  • Comprehensive knowledge in the application of quality management tools to non-manufacturing processes
  • Demonstrated experience with process improvement approaches, including change management
  • Expert use of Microsoft Window Suite, most notably with Excel and PowerPoint
  • Comprehensive knowledge of industrial safety programs and OSHA regulations
  • Industrial hygiene experience and OSHA training experience desired
  • Experience in ISO 9001, CMMI, Lean Six Sigma quality processes and OSHA VPP or FAA SMS
  • Excellent verbal and written communication skills, to include ability to work autonomously with very limited supervision as well as collaboratively with others
  • Minimum of a BS/BA degree in Continuous Improvement, Quality Systems and/or Safety & Industrial Hygiene
  • Minimum of eight years’ experience in any combination of the following areas
30

Manager, Quality Resume Examples & Samples

  • Minimum of 2 years’ experience in a clinical laboratory as a supervisor, manager or higher required
  • Comprehensive understanding of State and Federal laws pertaining to clinical laboratory testing and operations, and accreditation standards (FDA, JCAHO, CAP, AABB)
  • Possess strong analytical problem-solving skills and excellent communication skills including effective interpersonal aptitude to interact with a diverse group in a diplomatic manner
  • Participation in accreditation (FDA, JCAHO, CAP, State, etc.) inspections
  • Understanding of quality assurance requirements of JCAHO, CAP, AABB, FDA, CLIA, and State of California
  • Understanding of clinical laboratory quality control, CQI philosophy
  • Familiarity with State and federal laws and regulations governing laboratory practice, including physicians’ office testing, hospital bedside testing, scope of practice, Quality Control, Quality Assurance
  • Understanding of OIG compliance guidance for laboratories
  • Expertise in the use of desktop computer tools, including the Internet, Outlook, Excel, PowerPoint, and Word applications
  • Ability to write and implement policies & procedures
  • California Clinical Laboratory Scientist license or RN license required
  • ASCP certification as an MT preferred
31

Assistant Manager Quality Resume Examples & Samples

  • Collects and understands external and internal customers’ expectations or feedback on supplier quality, and cooperates with other top management personnel in formulating and establishing company policies, operating procedures, innovation plans, and goals for supplier quality
  • Analyzes, evaluates and presents information concerning factors related to suppliers and components such as new regulations, cost of quality, suppliers’ risks, supplier’s performance, and proposals to other members of management team
  • Cooperate with material or purchasing team to establish the supplier quality requirements and agreements
  • Lead SQE team to evaluate, develop, and monitor suppliers and components to ensure they comply with Flex requirements and customer requirements on safety, quality, capability, delivery, environment, society regulation, etc
  • Lead SQE team to measure and track suppliers’ performance and to drive problem solving and continuous improvement
  • Establish and maintain the supplier quality management process and tools, and train SQEs and all peers to ensure compliance of the supplier quality process
  • Commit cross-functional support and form good relationships with internal and external customers in order to maintain a strong support system in the organization, to achieve customer satisfaction and to comply with regulatory requirements
  • Demonstrates advanced/thorough knowledge of the function and Flex business
  • Must have good interpersonal and negotiation skills
  • Must have knowledge of supplier quality management and both national and international government regulatory agency standards
  • Use of the following skills/tools may be required
  • Electronic Assembly: color code, component, schematics, loading, touch-up, commercial soldering, mechanical assembly: surface mount assembly, point to point wiring; Cables: crimping, harness assembly, connector/wire soldering, cable prepping; Testing: oscilloscope, cable & harness testing, trouble shooting, component testing, logic analyzer; Inspection: bare board, loaded, systems, components, cable/harness, microscope, measuring tools; Machine Operations: automatic component insertion equipment, surface mount insertion equipment, wave soldering; Mechanical & Electrical Tools: power air guns, taps & dies, alignment tools, measuring tools; Office Skills: typing, telephones, computer languages, word processor, data entry, ten key, spread sheet (PC), software
  • Demonstrates advanced functional, technical and people and/or process management skills as well as customer (external and internal) relationship skills
  • Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents
  • Ability to effectively evaluate suppliers’ process, management system, capability, and make valid decisions
  • Ability to report and communicate the supplier evaluation and performance result to internal or external customers and peers
  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
  • Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
32

Manager, Quality Resume Examples & Samples

  • This role is to act as a member of the Process Improvement Unit (PIU), managing risk as global experts for in-line inspection & testing while reducing the cost of quality non-conformance
  • This role provides Application of technical expertise to develop and validate new and existing processes or process improvements
  • Organization and analysis of commercial, technical and process information to assist development and implementation of Process Improvements
  • Use experience to identify risk to product, packaging and business evaluating potential impact of Process Improvements
  • To support the delivery of the FS & Q strategy
  • Assist in the development of PIU planning process
  • A saving in material, labour and utilities of $XXMM /year via identifying losses and waste & rectifying them
  • Manage PIU category team of Project Implementers (bands 4-5)
  • Bachelor’s Degree, ideally in an engineering or science related discipline
  • Significant food industry experience in an Operational or Quality role
  • Ability to identify and understand food safety and quality issues
  • A proven goal orientated self-starter capable of being remotely managed
  • Team player, capable of working in areas outside of expertise by drawing on team skills when required
  • Highly proficient project management skills and ability to manage changing project deadlines and priorities with ease
  • Task focused with strong organizational and planning skills
33

Manager, Quality Resume Examples & Samples

  • Be accountable for all quality aspects on the program leading to a successful delivery of aircraft
  • Develop and deploy the Quality strategy for the business units within Q400 Program
  • Ensure adherence to the Bombardier Quality Management System requirements throughout the supplier chain
  • Deploy the Advanced Quality Planning (AQP) deployment for internal manufacturing activities as well as for suppliers
  • Define Quality KPIs & governance, ensure proper training and development of team members
  • Ensure a strong & continuous alignment with your quality peers from Toronto
  • Develop manufacturing processes and optimize internal and external processes
  • Promote and act as a leader for Achieving Excellence System implementation
  • Respect schedules and business plans associated to the various phases of a program launch
  • Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with Quality strategy
  • You hold a Bachelor's degree in Business, Management, Engineering, Operations or eight (8) years of relevant experience, including two (2) years experience in management
  • Aerospace Industry experience a MUST with a strong knowledge of our products
  • You have experience in quality
  • You are familiar with Transport Canada Civil Aviation requirements and regulations
  • You have a good knowledge of Advanced Quality Planning tools (FMEAs, process control plans,etc)
  • Your English is excellent written and spoken. French is an asset
  • You have the capability to work with concepts and translate them into solid execution plans, good project management skills
  • You are recognized for your leadership, your strong client-facing, communication and coaching skills, for your ability to mobilize and engage a team
  • You could be required to travel from time to time
  • You are flexible to work outside the standard work hours (if need be)
34

Manager, Quality Resume Examples & Samples

  • This role supports the implementation and execution of key microbiology and food safety programs within a specific business unit. Role includes reviewing product/process design with R&D to ensure food safety, and designing challenge studies when & where required. The position provides HACCP plan development and validation support to internal/external plants. He/She will work with the a Business Unit on microbiological and food safety related issues and partner with central Quality and R&D functions on development and implementation of policies & procedures
  • This role provides scientific and technical food safety and microbiological support to the BU/Region to ensure product safety and quality by participating in evaluation of suppliers and co-manufacturers. Identify and communicate food safety risks to BU/Region, giving actionable advice on Food Safety programs
  • Work with business partners where improvements and execution of relevant HACCP models, zoning and environmental monitoring are required at pilot plant facilities, suppliers/external manufacturers
  • Conduct validation of Critical Control Points related to heat kill steps (Cooking, formulation, etc.) and assess validity of data obtained by others
  • Work with Product Development/R&D to design in food safety/quality controls and provide risk evaluation to the Business Unit
  • Work Cross-functionally with Quality, Supplier food safety, and procurement to establish food safety specifications for ingredients and ensure compliance
  • Design and execute challenge studies, shelf-life studies and validation studies to determine critical limits for critical processes. Partner with external institutions and business partners to update/maintain CCP models
  • Conduct validation studies to evaluate and approve microbiological test methods (rapid and cultural) for the Kraft Heinz Laboratory network
  • Remain current in scientific and regulatory principles of food safety to ensure most relevant information and emerging issues are identified and incorporated into Kraft food safety programs
  • PhD in Food Safety, Microbiology or closely related field and 1 - 3 years of experience in applied microbiology or related discipline
  • MS in Food Safety or Microbiology or closely related field and 3-5 years of experience in Food Safety or related discipline
  • Prior HACCP certification preferred
  • Knowledge and implementation of HACCP and Food Safety practices
  • Knowledge and understanding of regulatory requirements
  • Knowledge and understanding of Good Manufacturing Practices, Pathogen Environmental Monitoring, and Facility / Equipment Design
  • Experience with microbiology laboratory techniques and rapid test methods
  • Awareness of quality systems/processes (ISO, Six Sigma etc.)
  • Excellent communication skills (presentation, report writing, teaching/training)
  • Good people skills
  • Work experience in team oriented functions as well as individual contribution
  • Action oriented with good project management skills
35

Manager, Quality Resume Examples & Samples

  • Responsible for team building, identifying resource gaps, and working in collaboration with HR to create personal development plans to enhance the capabilities of the Quality department
  • Work with the Quality Engineering team to create and manage final and process yield improvement initiatives to meet company objectives
  • Supports Product Development, Operations, Engineering, and Manufacturing, to resolve technical issues by implementing corrective and preventive actions and reporting on status, as applicable
  • Provides input on quality metrics for areas assigned as presented for Management Review
  • Accomplishes results through subordinates
  • Participates in internal and external audits representing Quality for the areas assigned
  • Drives continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams
  • Develops, manages and executes Quality Plans
  • Manages quality systems in compliance with ISO 9000 guidelines
  • Ensures compliance with applicable regulatory requirements and internal procedures for product designs and manufacturing processes
  • Develops and analyzes statistical data and product specifications to assure attainment of quality objectives
  • Applies Total Quality Management tools and approaches to analytical and reporting processes throughout product life cycle
  • Designs and implements quality control/assurance training programs for key personnel to assure development of quality department team and other functions team members
  • Proven record of Quality system implementations
  • Proven record of initiating and driving continuous improvement
  • Proven record of high level customer communication, conflict resolution, and negotiation skills
  • Must have knowledge of Quality Engineering discipline, including statistics. ASQ Certified Quality Engineer preferred
  • Established collaboration skills and the ability to communicate with openness and transparency
  • Strong organizational skills through demonstrated ability to multi-task and manage time
  • Ability to work well under pressure with various departments
  • Strategic Thinker – able to identify critical and long range opportunities
36

Assistant Manager Quality Resume Examples & Samples

  • 2 Manage site Quality Control program including but not limited to calibrations management, monitoring of compliance to defined processes (e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of KPIs, root cause and failure mode impact assessment and change management
  • 3 Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Lead by example; consistently motivate staff through education to high levels of competency that drive success in a dynamic and regulated environment. Upon proper review with center and quality management, recruit, hire, conduct performance reviews and enact corrective actions, up to and including termination
  • 4 Participate with management to develop programs and methods to streamline center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality. Working knowledge of the change management process and appropriately raise ideas for consideration for change locally and upward to quality and area management
  • 5 Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies
  • Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others, OR
37

Senior Commercialization Manager Quality Private Brands Consumables Resume Examples & Samples

  • 7+ years of experience in CPG manufacturing, operations, and product & supplier quality management systems
  • Experience in daily-use, high-repeat purchase product categories such as Grocery, Household, Personal Care, Beauty, Health & Wellness, and Baby Care
  • Experience creating, implementing and maintaining internal quality systems/document management systems, standards/SOPs for internal and external applications
  • Experience in new product development and successfully launching new products to volume
  • Experience assessing supplier capability to deliver quality products to market and defining associated technical test parameters for new and current products understanding the end-to-end manufacturing and supply chain implications
  • Comfortable communicating and presenting to senior management and cross-functional teams in a way that enables non-technical team members to understand the quality requirements and metrics
  • Ability to manage multiple simultaneous projects requiring frequent communication, organization/time management and problem solving skills
  • Demonstrated ability to own projects, think big, act quickly, and influence across all levels of an organization
  • Certification in Six Sigma Green Belt and Lean manufacturing
38

Manager, Quality Resume Examples & Samples

  • Lead and manage the development and maintenance of the quality system and all of its processes to ensure that the cars produced satisfy all given customer, regulatory, and Company requirements
  • Analyze and communicate rejects to all appropriate supervisors. Establish and implement reduction plans based upon analysis to satisfy Maintenance Group’s Initiatives
  • Oversee the audit process in the facility, including AAR audits, internal audits, process audits, and Field Operations audits, in order to continuously improve all aspects of the quality process
  • Control and communicate documents pertinent to the quality system, to all affected personnel including: Quality Procedures, Fleet Maintenance Instructions, Engineering Notices, Improvement Orders, AAR Circular Letters, and Qualification records
  • Participate on cross-functional teams to evaluate, define, and improve our processes to ensure alignment and achievement of GATX Rail Maintenance Group’s Initiatives
  • Serve as the technical liaison for researching, analyzing, and communicating on quality related issues to regulatory bodies and GATX Rail Leasing and Maintenance functions
  • Bachelor’s degree with concentration in Engineering, Operations or related field or Associate’s Degree or equivalent experience
  • Three to five years’ experience in related industry, including quality experience (TQM< ISO 9000, M1003, SPC, etc.)
  • Must have successfully completed one of the following: AAR Auditor Qualified Advanced Class, Excel Auditor-Internal Auditing for ISO 9001 or, ASQ Certified Auditor
39

Manager, Quality Resume Examples & Samples

  • Designing and implementing Quality systems which comply with Corporate Policies, training staff and key personnel in order to attain strategic objectives, along with providing management quality trend information to aid in achieving these objectives
  • Managing and developing all personnel within the Quality function in order to maintain and improve overall efficiency of plant operations
  • Supervise and support product validations and designs
  • Establishing documentation required for the implementation and maintenance of quality systems and compliance to applicable International standards, such as ISO13485, ISO 17025, 21 CFR 820, MDD 93/42/EEC, SOR/98-282, J-GMP (i.e., PAL) and other as applicable
  • Perform Risk Assessment, as applicable, following ANSI/AAMI/ISO 14971 standard
  • Providing support for the administration of Project Management, Design Control, Research, Development & Engineering efforts within the facility
  • Initiating and directing corrective actions to problems relating to product or process quality, such as complaint resolution, customer interface, regulatory action
  • Providing liaison between the operations management and applicable regulatory agencies regarding audit findings, litigation, and complaints
  • Establishing and implementing quality systems that will support the key strategies for the plant with emphasis on continuous value improvements in total cost, quality, service, and innovation
  • Improve facility operations through implementations of quality management specifications, procedures, test methods, and measurement systems
  • Minimize customer complaints due to product quality through effective corrective action systems
  • Ensure compliance of plant operations to appropriate regulations and standards and act as site management representative
  • Work cross-functionally with all other business unit functions by maintaining productive working relationships and promoting QA involvement
  • Manage departmental spending with the budget
  • Manage, supervise and develop direct reports
  • Ensure all key items for maintaining ISO and CE certifications are addressed: serve as main contact for external agencies, coordinate effective management reviews, including gap analyses, coordinate training of the Quality Systems, and support the maintenance of the associated product Technical Files. Designated Management Representative
  • Evaluate the impact of any new product or changes to existing products on regulatory applications
  • Comply with local and federal Environmental, Health and Safety Regulations, such as OSHA, EPA and other standards and guidelines
  • Direct supervision of Quality Assurance personnel
  • Excellent interpersonal and communications skills at all levels
  • Fully bilingual (Spanish/English)
  • Bachelor’s Degree, preferably in a technical field related to engineering or science
  • 5 years experience in Quality Management and Regulatory Affairs, medical device manufacturing, FDA (CFR 820) and ISO/EC requirements, statistics and sampling methods
  • Six Sigma Engineer or ASQ Certification in Quality Engineering or Quality Management, preferred
40

Manager Quality Resume Examples & Samples

  • Support the Company''s mission, vision, values and goals in the performance of daily activities
  • Responsible for performance feedback and leadership of all direct reports including mentoring, coaching, counseling and corrective action when situations dictate
  • Ensure product and process compliance to customer and TS 16949 requirements
  • Support corporate in standardization activities
  • Provide direction and leadership to department colleagues consistent with plant business plan goals
  • Direct the utilization of and participate in problem solving methods for related plant and customer problems / issues
  • Serve as driver and coordinator for internal quality systems audits and corresponding corrective action and improvement activities
  • Create an environment conducive to the maintenance of high quality standards
  • Provide key input into the development of the plant''s strategic business plan along with identifying and tracking key measurable to support the business plan goals
  • Develop and drive the development of departmental strategy and goals along with identifying and tracking key measurable to support the goals
  • Use company metric format to effectively track monitor and implement required corrective/improvement activities related to business plan, goals, issues, etc
  • Develop and drive implementation of a progressive quality system to prevent defects and exceed customer expectations and achieve customer/quality awards (ex. TS 16949, Q1, etc.)
  • Develop and drive implementation of all quality policies and required operating procedures and work instructions
  • Oversee the activities of required customer actions to assure timely and proper responses
  • Develop and maintain Level II (operating procedures) and Level III (work instructions) documentation as required with appropriate input
  • Oversee proper and timely quality related participation in advanced product and process planning activities (i.e.; Planning, Control Plans, Capability Studies, PPAP, etc.)
  • Represent the company during customer visits and surveys, and during meetings and presentations at the customer''s location
  • Receive and disseminate information from the customer requirements
  • Assure the correct use of inspection equipment and data gathering / analysis, and whenever possible utilize latest technology applications
  • Maintain a current knowledge of quality assurance and control techniques
  • Ensure accountability and discipline within the department
  • Assure all safety devices are properly in place and utilized, and to verify individual usage of personal protective equipment by the entire work team
  • Comply with all internal and OSHA required safety procedures in the performance of daily activities and hold all direct reports accountable for enforcement
  • Adherence to all company policies and procedures (ex. Quality Policy Manual, Colleague Handbook, Level II Procedures, etc.)
  • Provides direct leadership and supervises the Quality Department
  • Ability to identify, select, train and coach management talent
  • Bachelor''s Degree in Engineering, Management or Business, appropriate ASQC certification or equivalent experience
  • Minimum 5 years as a quality assurance manager or equivalent experience
  • Knowledge of quality tools, practices, systems and corresponding integration
  • Excellent organizational, analytical and communication skills
  • Ability to mentor and teach the team effective problem solving
  • Proven leadership ability and excellent interpersonal skills
  • Vision and ability to translate progressive quality and operating techniques into applications and results
  • Good working knowledge of customer required software (ex. Powerway, etc.)
  • Familiar with GD&T
  • Familiar with PPAP, APQP, TS and other customer specific requirements
41

IT Manager, Quality Complaint Management Resume Examples & Samples

  • Sets a clear vision for the product and is responsible for multi-generation product strategy
  • Maximizes ROI by identifying and prioritizing the product features by their business value in close partnership with the JJQS&S product owners
  • Accountable for the TCO of the platform(s)/system(s) and driving increased leverage across various business units and segments
  • Establish and lead the System/Platform Governance Board
  • Primary IT interface with the business for specific capabilities within the product line
  • Understand the business’s needs and priorities for the product
  • Understands economic models to manage prioritization and applies systems thinking
  • Negotiates with the business, in partnership with the Business Technology Leader (BTL), to see which user stories in the backlog are prioritized based on available capacity and
  • A minimum of a bachelor’s degree is required, an advanced degree is strongly preferred
  • A minimum of 5 years of relevant experience is required
  • A minimum of 3 years relevant Quality Systems experience is required
  • Relevant knowledge of Complaint Management solutions and processes is required
  • Experience working with business partners at a variety of management levels is required
  • Strong IT skills/background with specific focus on Quality Systems is required
  • Experience in managing and leading complex IT projects is required
  • Demonstrated architectural, process development/improvement and systems design skills is required
  • Demonstrated leadership, influencing skills, and relationship management (business and vendor) is required
  • An understanding of Computer Systems Validation is required
  • Strong verbal and written communication skills including formal presentation skills is required
  • Budget Management experience including planning, tracking and partnering with finance to ensure commitments are met is required
  • Knowledge in Platform service and operations, Infrastructure delivery, Information security/internal controls is preferred.IT Compliance
42

Manager, Quality Resume Examples & Samples

  • Directs and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output as possible
  • Ensures timely resolution to audit findings and customer complaints
  • Utilize PMI strategies and techniques to manage Scope, Time, and Budget
  • Maintain clear communication paths with stakeholders
  • Conduct routine project management reviews with project Teams and management
  • Manage and maintain an effective Quality Assurance program for the plant in alignment with Global Operating Procedures and capable of maintaining ISO 15378 certification status
  • Review operating procedures to ensure compliance with all related procedures, instructions and the Quality Manual
  • Investigate and ensure implementation of the corrective actions associated with non-conformances, including, customer audits and complaint reports
  • Conduct plant Quality Management Review meetings of the plant quality system
  • Establish and monitor plant Quality Metrics used to evaluate the effectiveness of the Quality System
  • Establish procedures and methods to comply with applicable GMP, ISO requirements and customer expectations
  • Manage Quality Staff at site to assure knowledge and execution of site Quality System
  • Drive continuous quality improvement projects at plant based on site data and customer expectations
  • Drive compliance to global harmonization initiatives
  • Assure proper use of change management associated with validated processes used by site
  • Assure execution of internal audit program
  • Adjust in process/final sampling plans & related accept/reject criteria to ensure compliance to specification
  • Performs other duties as assigned based on business needs
  • Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
  • Education: Bachelor's in
  • Science or Engineering, or commensurate experience
  • Experience: 6-10 years of experience
  • Minimum six (6) years in Quality Assurance / Quality Control. One (1) year managing others
  • Experience with sterilization requirements and classified environments for production
  • Experience with Customer interface and meeting customer expectations
  • Working familiarity with Project Management Tools and Quality Risk Management
  • Experience with microbiology and particulate lab testing
  • Working knowledge of Pharmaceutical Industry requirements for elastomeric closures
43

Manager, Quality Resume Examples & Samples

  • Manages the B5 Teardown and Fractionation Quality Assurance organization for a large size plasma fractionation facility
  • Hire, train, coach, supervise, develop and retain staff
  • Understand and ensures compliance to all applicable Baxter policies and procedures as well as state, federal and international regulations
  • Deploy the quality systems that ensure products conform to defined requirements
  • Perform multiple responsibilities in the CAPA process
  • Provide quality input and approval of change control
  • Responsible for adherence to specifications and procedures that have been established to ensure product quality
  • Support, interact and help manage regulatory inspections
  • Interacts frequently with all levels of internal management as well as across facilities and business units
  • Manages interactions with customers and regulators concerning the quality of products, systems and processes
  • Partner with operations, especially Building 5 manufacturing counterparts, to ensure compliance and timely resolution of quality related items
  • Interacts frequently with subordinates, peers and senior management in ensuring the success of the business
  • Participate in or manage quality assessments of internal operations and / or suppliers to analyze compliance and assess risk
  • Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, Eudralex, and Shire quality requirements
  • Support the project initiatives within the LA facility
  • Support the development and maintenance of the department budget for Fractionation QA
  • Thorough knowledge of the regulatory environment for manufacture of therapeutics/biologics
  • Thorough knowledge of quality system processes, especially CAPA, Change Control, and Batch Record Review
  • Strong leadership skills and demonstrated success in managing a team
  • Success working with multifunctional, global teams
  • Good interpersonal, influencing, and negotiation skills required
  • Knowledge of Plasma Teardown and Fractionation Process helpful
  • Knowledge in DeltaV or automated control systems helpful
  • Bachelor’s degree in Science or Engineering; advanced degree in the life sciences, physical sciences or engineering preferred
  • 5+ years in Quality, Manufacturing, Engineering or related field in the biotech/pharma industry
  • 1-2 years of supervisory experience
44

Manager Quality Resume Examples & Samples

  • Provides Regulatory and AS9100 compliance/oversight of Repair and Overhaul operations
  • Establish and attain Quality and HOS performance goals and improvement objectives, including improvements in Cost of Poor Quality (COPQ), internal and external escapes, RCCA completion and HOS implementation and maturity
  • Ensure compliance to the Honeywell Quality Management System (QMS) in order to ensure adherence to customer requirements, regulatory statues, government regulations and engineering specifications
  • In conjunction with ISC STRAP and AOP processes, partner with site leadership to develop and deploy the site ISC strategy
  • Ensure proper execution of all internal and external audit programs including a management review process that requires leadership engagement in the site’s overall QMS
  • Develop and maintain a system to assure that all products manufactured and serviced by the organization meet customer requirements while achieving superior quality and reliability levels
  • Drive a robust Root Cause Corrective Action (RCCA) process across the organization and champion internal and external escape reduction initiatives; ensure the completion of corrective actions through eCats and CAR’s in order to prevent recurrence
  • Lead Integrated Supply Chain process excellence and best practice sharing within the site and across the ISC function in order to develop ‘best in class’ manufacturing operations
  • Lead multi-functional project teams to address tactical and strategic needs and improve supply chain efficiency
  • Partner cross functionally and cross site to drive quality and design improvements
  • Provide quality support for product transitions; implement product and process improvements and controls to assure sustained product quality results upon completion
45

Assistant Manager, Quality Resume Examples & Samples

  • Ensures the activities and controls used to determine the accuracy and reliability of the establishments’ personnel, equipment, reagents and operations in the manufacturing of blood products including testing and product release
  • Collaborate with center management to ensure compliance with all relevant regulations, laws, standards and Company policies, and that the Center is “inspection ready” at all times
  • Lead quality team to ensure all staff is competently performing their duties as evidenced by findings of a program of monitoring, tracking and trending of key metrics
  • Responsible for hiring, retention and development of quality staff
  • Lead investigations to determine root causes, corrective/preventative actions and appropriate coordination/leadership of process improvements
  • Proactively facilitate communication and interdepartmental coordination quality issues and host audits
  • 6 Lead and function as the key quality representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of audits timely. Utilize quality tools and applications to facilitate understanding of issues and documentation
  • 7 Maintain clean efficient work environment and ensures sufficient operating supplies and availability of forms, as needed. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary. Promote safety in all actions
  • 8 Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance and ensure center management is doing the same
  • 10 Responsible for notification to the ADOQ for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance
  • 11 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper immune programs at the center if applicable
  • 12 Lead investigations and deviations to determine root cause, correction/preventative actions and effectiveness checks. Monitor CAPA’s and effectiveness checks to ensure issues are resolved
  • 1 year Quality experience (CSA/CSAb) required OR
46

Manager Quality Detroit Resume Examples & Samples

  • Report the performance of the QMS timely to the Plant Manager and Corporate Quality Management
  • Manage quality-related issues with customers and suppliers
  • Ensure the implementation of adequate preventive and evaluation tools, e.g.: Product inspection and testing, FMEA, Poka Yoke, etc
  • Manage Non-Conforming Products and control the “Quarantine” area
  • Manage quality-related issues coming from PMR
  • Communicate and promote cooperation with all other Kautex Plants / Departments in order to share experiences and achieve quality targets
  • Minimum of 5 years experience in quality related position
  • Knowledge of manufacturing techniques and business systems, e.g.: 5S, standardized work, Kanban, visual management
  • English language skills are required
47

Manager Quality Footwear Resume Examples & Samples

  • Cconducts modular/full QIP audits at all T1s and rates the T1 QIP set up, implementation and performance status in collaboration with Senior Manager Quality (QIP) and/or the Director Quality
  • Conducts random finished goods inspection and Beautiful Audits at T1 factories
  • Supports T1s in driving standardized problem solving/root cause analysis and follows up on implementing sustainable solutions
  • Supports Senior Manager Quality in facilitating cross-functional events (e.g. T1 cross-visits; combined Workshops with T1, LO Prod & Dev.) to identify short-, mid- and long-term Quality improvement opportunities
48

Manager Quality Inspections Resume Examples & Samples

  • Accountable to the Director, Gas Materials & Standards with primary responsibility for directing and managing the activities of the MEQIP / NDE staff related to our Quality Inspection Programs
  • Manage a diverse group of employees with concern for staffing, training, professional competence, productivity, and performance appraisal to ensure the department is adequately staffed, operates efficiently, and can adapt to changing requirements
  • Co-ordinate with Internal and External Customers, Contractors and Vendors to build working relationships and manage them to meet established policies and processes
  • Lead the creation of analytics and reporting to identify systemic operating, process, or technological deficiencies within the Department
  • Develop and implement solutions that address systemic problems impacting productivity and optimal operating
  • Exercise independent judgment in managing daily operations and resolving issues while remaining accountable for all actions to next-level management
  • Must be able to work in a multi-faceted, process centric, high performance team environment with an understanding of how individual responsibilities impact the larger organization accountabilities
  • Accountable for auditing NDE contractors and performing work in the field during emergency
  • Bachelors Degree in Engineering or equivalent. Minimum 15 years experience in gas operations and supervision or engineering in lieu of degree
  • Requires ASNT Level 3 or 2 certfifications in NDE methods (RT/UT/MT/PT)
  • Requires AWS CWI certification
  • Demonstrates the ability to apply and modify complex theories and learned concepts appropriately
  • Requires broad technical knowledge of Gas Materials Standards, federal and state regulations, work methods, including welding, NDE Standards, equipment and gas field operations
  • Demonstrates strong interpersonal skills including influencing change and management of staff. Lets people affected by a decision know what’s happening and is able to clearly articulate reasons for a decision
  • Knowledge and understanding of issues affecting the industry. Demonstrates the ability to anticipate obstacles and think ahead about next steps
  • Knowledge of safety policy and potential hazards of the gas distribution network
  • Knowledge of gas materials and the ramifications of poor quality affecting the gas business
  • Significant exposure to large scale process improvement efforts
  • Proficient in Excel, Word, PowerPoint and other MS Office applications
  • Demonstrated proficiency in managing a team, communicating expectations, and delegating responsibilities with the ability to build effective working relationships
  • Experience in investigating issues using various amounts of data and working with multiple tools to define root causes
  • Able to assess business issues, define the process, and bring unique solutions to business problems
49

Manager, Quality Resume Examples & Samples

  • Defines and specifies the implementation of standards, methods, and procedures for inspecting, testing and evaluating the precision, accuracy, and reliability of company products
  • Participates in the reviewing of engineering designs to contribute quality assurance requirements and considerations
  • Assists product support areas in gathering and analyzing data
  • ISO coordination and incoming inspection are also key areas of responsibility for this position
  • Provides guidance to subordinates to achieve goals in accordance with established policies
  • Establishes and recommends changes to policies which affect subordinates organizations
  • Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules
  • Frequently interacts with subordinate supervisors, customers and /or functional peer group managers. May interact with senior management
  • Manages, through subordinate supervisors, the coordination of activities of a section or department with responsibility or results in terms of costs, methods, and employees
  • In some instances this manager may be responsible for a functional area and may not have subordinate employees
  • 5 – 8 years of quality assurance experience
  • Equivalent combination of education and experience may be considered
50

Assistant Manager Quality Resume Examples & Samples

  • Execute Training to personnel in Quality dept. in relation to CAN Lab Safety Requirements and Compliance to Use of CAN approved chemicals and reagents, SOP’s, Instrumentation, Documentation and Personnel safety
  • Preparation & review of Annual product quality reports, Monthly Quality Reports/ MRM meeting requirements on a periodical basis
  • 2+ years experience in a Quality control department and handled HPLC, GC, AAS, LOD, moisture, Melting point intstruments. Qualification and validation of instruments
  • 3+ years experience in Quality Assurance department
  • Prior experience in a secondline reporting is preferred
  • Experience in executing job through ambiguity
51

Manager, Quality Resume Examples & Samples

  • Ensures operations delivery of client requirements as per contractual agreement
  • Directs and monitors adequate staffing levels to meet quality and budget standards
  • Assists in defining and establishing ongoing performance measures for centre personnel
  • Meets shrinkage and budgetary requirements for staffing and expenditures
  • Assists Director to establish centre budgets
  • Liaise with client regarding day-to-day center activities
  • Promotes positive employee relations
  • Monitors client expectations and insures effective communications to centre employees
  • Identifies performance and expectation gaps and facilitates resolution
  • Assists Client Services support to identify possible new business opportunities
  • Identifies operating opportunities for continuous improvement and efficiencies
  • Insures maintenance of standards and objectives related to ISO/COPC compliance
  • Education / Knowledge: College course completion or equivalent experience; thorough understanding of Call Centre operations, principles and metrics
  • Experience / Skill: Minimum 5 years of Call Centre experience, including 3 to 4 years in management capacity; demonstrated experience analyzing and resolving customer service and client issues; in an inbound/outbound requirement
  • Call Center Experience
  • 3 to 4 years of Management Experience
52

Manager Quality Assuranceus Resume Examples & Samples

  • 5 to 7 years direct experience in overseeing the design, development, and implementation of quality assurance standards for software testing
  • Five years direct experience as a QA Manager for major application integration and/or major application product release
  • At least 5 years direct experience managing all aspects of a QA team
  • Strong knowledge of system testing metrics, best practices and methodologies
  • Direct hands-on experience with ad hoc query programs, automated testing tools, and reporting software
  • Extensive practical knowledge in importing data for use in report software, spreadsheets, graphs, and flow charts
  • Proven data analysis, data verification, and problem-solving abilities
  • Good project management skills and/or substantial exposure to project-based work structures
53

Manager Quality Resume Examples & Samples

  • Act as plant contact for sales and customers on quality issues
  • Conduct employee appraisals and evaluations
  • Customer Relations Responsibilities
  • Ensure adequate staffing and training of new employees
  • Implement McCain Competitive Edge and Lean Manufacturing practices relative to Safety, Quality, Cost, Delivery and Personnel (SQCDP)
  • Maintain system to keep informed of relevant legislation
  • Oversee the evaluation and disposition of all returned products
  • Provide customers and potential customers with product information
  • Responsible to respond to all quality complaints to the Corporate Quality Assurance personnel
  • Manages and coordinates the Quality Assurance Department
  • Act as plant contact for all Kosher activities with the Jewish Orthodox Union
  • Administer the operation of the plant food safety committee
  • Communicate with management on product quality issues
  • Ensure quality standards of the company and customers are met or exceeded
  • Monitor plant sanitation issues
  • Oversee the daily operation of the HACCP plan. Conduct plan reviews and updates plan as necessary
  • Responsible for the testing and evaluation of all quality attributes in the finished product
  • Responsible to insure adequate test equipment and materials are on hand to conduct required sampling/tests
  • Review help product and make necessary disposition
  • Supervise all Quality assurance personnel. This involves hiring, training, scheduling and evaluating all QA personnel
  • Miscellaneous Duties
  • Act as plant contact for all quality audits to include customers, regulatory agencies, and 3rd party
  • Responsible for developing and managing department budget
  • Travel as necessary to perform customer relation duties
  • On-site Requirement - Must perform duties onsite
  • Schedule employee work schedules and vacations
  • Work closely with production managers to insure quality standards are met
  • Other projects/duties as assigned or needed
  • Supervise all personnel and activities within area of responsibility
  • Ability to monitor and manage multiple projects
  • Four-year degree from college or university and/or five years of production experience
  • Strong leadership, reasoning, and judgment will be required to facilitate proper planning
  • Minimum of 3 years in the food processing, manufacturing environment
  • While performing the duties of this job, the employee is regularly required to stand; walk and reach with hands and arms. The employee is frequently required to use hands to finger, handle, or feel; stoop, kneel, crouch, or crawl and talk or hear. The employee is occasionally required to sit; climb or balance and taste or smell. The employee must regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus
  • While performing the duties of this Job, the employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; extreme cold; extreme heat; risk of electrical shock; risk of radiation and vibration. The noise level in the work environment is usually loud
54

Manager Quality Resume Examples & Samples

  • Develop, implement, maintain and improve Quality Systems at the plant. Fulfil corporate mandate as directed by the Vice President of Quality Assurance
  • Responsible for the maintenance of the Good Manufacturing Practices (GMP) standards
  • Oversee and manage the QC department resources, both budgetary and staff
  • Responsible for the development of the staff in the areas of health and safety, performance development, QC process training, and education programs, succession planning, etc
  • Responsible for audit process involving both product and internal system. Site leader for the AIB Gold Standard Certification process
  • Responsible for the facility HACCP System
  • Implement, maintain and improve the system for measuring and reporting current quality status at the facility
  • Develop and manage the facility sensory program
  • Maintain customer complaint investigations program, ensuring timely reporting of analysis
  • Act as representative for McCain Foods, responsible for developing and fostering positive customer relationships
  • Responsible for various monthly reports to National Quality Control Manager in timely manner
55

Manager Quality Excellence Resume Examples & Samples

  • Must be able to coach and communicate effectively with external suppliers/stakeholders and all levels of the organization to negotiate, influence and enforce Quality and Company policies
  • Bachelor’s degree in engineering, technical engineering or science discipline or combination or equivalent experience
  • Six Sigma Black Belt or Master Black Belt
  • Must have 3-8 years of lean six sigma, operations, manufacturing or supplier quality, experience
  • Ability to execute Quality methods and systems (statistics, reliability, sampling, and auditing, problem solving)
  • Interpersonal and communication skills are essential for dealing with all levels of internal and external suppliers and customers
  • Problem solving background
  • ISO / QS / TS / FDA quality system working knowledge and auditing experience
  • Microsoft Office software skills including Excel, Word and PowerPoint
56

Manager, Quality BMT Resume Examples & Samples

  • Develops, revises and implements the required Bone Marrow Transplant Quality Plan
  • Develops, analyzes and documents the required studies that measure the quality of care and outcomes for patients
  • Plans, coordinates and maintains regulatory compliance with accreditation standards
  • Acts as a resource and consultant for performance improvement which includes identifying problematic quality related issues, defining criteria for evaluation, monitoring PI activities, preparing a summary of findings, comparing data with appropriate benchmarks, designing and coordinating action plans and monitoring follow-up steps
  • Performs oversight of all elements of the Clinical Program Quality management activities which includes coordinate audits, ensuring compliance with regulatory/accreditation requirements, and developing reporting schedules and formats
  • At the direction of the Administrative Director, facilitates activities related to FACT (Foundation for the Accreditation of Cellular Therapy) accreditation
  • Completion of RFI documents for insurance payors
  • Develops, revises and implements policies/procedures for the BMT program
  • Coordinates required education for accreditation standards, policies and procedures with appropriate education personnel
  • Assists with development and review of clinical BMT algorithms and standard of care guidelines
  • Coordinates and facilitates all activities of the BMT Quality Management Committee and BMT Morbidity and Mortality Committee
  • Facilitates completion and tracking of clinician competencies and continuing education as required by accrediting bodies
  • Coordinates the data management staff regarding forms completion, queries, standard annual reports and productivity audits
  • Coordinates standard programing efforts for the BMT specific Electronic Medical Record forms to meet regulatory requirements
57

Manager, Quality Resume Examples & Samples

  • Manage tactical IVD operations on behalf of the QA department, ensuring compliance to CFR 820, QSR, and ISO 9000 requirements. Assist in managing compliance to CLIA and CAP laboratory requirements
  • Support senior QA management in the development, implementation, and maintenance of Ignyta Quality Systems, ensuring compliance with applicable regulatory requirements
  • Oversight and support of Master Control document control system, including document review, approval/release and archiving activities
  • Manage validation, CAL/PM program through review of equipment qualification protocols, calibration and maintenance records, and maintain Equipment History Files
  • Maintain company training program and records. Conduct companywide trainings on GxP requirements as necessary
  • Assist in ensuring the company maintains its compliance with GLP, GCP and GMP where required
  • Assist senior QA management with Vendor Oversight, qualification, and maintenance. Assist, and sometimes lead, internal and external audits across GxP functions
  • Manage the Management Review Program
  • Liaise with company personnel and CxO contacts to ensure a full understanding of Ignyta and regulatory requirements internally and externally
  • Supports senior QA management in interactions with external regulatory support
  • 5-7 years industry experience in quality-related position
  • Ability to develop and implement quality systems for clinical and commercial drug products
  • BS Degree in relevant field
  • Experience with IVD/FDA related QSR implementation. (Not required but a plus.)
  • Strong consideration for additional experience or proficiency in CLIA or CAP compliance
58

Manager Quality Resume Examples & Samples

  • Maintains product quality by enforcing quality assurance policies and procedures
  • Prepares product and process quality reports by collecting, analysing, and summarizing information and trends
  • Completes quality assurance operational requirements by scheduling and assigning employees; following up on work results
  • Maintains professional and technical knowledge by attending educational workshops
59

Manager Quality Avilla Resume Examples & Samples

  • Ensure that processes needed for the QMS are established, implemented and maintained
  • Organize job assignment for department's quality functions
  • Ensure that for all employees all HR development requirements and activities are in place and gaps closed
  • Ensure that Customer's and Kautex' requirements are addressed and satisfied
  • Act as the appointed Management and Customer Representative for Quality Management at Plant level
  • Ensure compliance with all federal, state and local laws, government regulations and internal guidelines
  • Maintain control of internal/external quality-related documents and records
  • Ensure that all specific issues regarding EHS and quality are implemented and observed in line with OHSAS 18001 and TS 16949
  • Bachelor's degree, Engineering or comparable education
  • Certified Quality Representative national authority (e.g. DGQ)
  • Certified Internal Auditor by KAUTEX or external body
  • 3 years professional experience in automotive industry is preferable
  • Experience in negotiation with customers and suppliers
  • Product knowledge is important
  • Knowledge of applicable customer-specific requirements
  • Knowledge in statistics, FMEA, Control Plan APQP, PPAP, SPC, MSA, DOE and product and process capability
  • Promote awareness of the importance of the key quality related jobs
  • Ensure knowledge about and compliance with customer service requirements throughout your team and if necessary, define training measures
60

Manager, Quality, Global Resume Examples & Samples

  • Plan, implement and control functional activities in order to achieve Business Unit targets
  • Manage, coach, develop, and provide feedback to a group of Quality Line Managers and employees
  • Ensure that all team members understand their role and performance in achieving the Business Unit targets
  • Utilize problem solving, corrective action and continuous improvement tools to ensure best practices are being developed and implemented within our quality management system via product and process assurance with our manufacturing line
  • Maintain and ensure budgetary requirements of the responsible departments
  • Ensure a safe working environment for our employees
  • Ensure the right resources are available to meet projected workload delivery on quality, cost and schedule
  • Maintain an equitable work environment
  • You have university degree in a technical, quality, or program management discipline is preferred
  • You have a minimum five (5) years management experience in Quality (Aviation experience preferred)
  • You have valid AME license or equivalent would be an asset
  • In depth knowledge and experience in Quality Control / Assurance, corrective and preventive actions methodology, and manufacturing systems
  • You are knowledge in working with unions and collective agreements would be an asset
  • You are strong interpersonal and negotiation skills
  • You have ability to adjust priorities and manage time wisely in a fast-paced environment
  • You are a successful candidate possesses the following: ethics, integrity and honesty; respect for others; cooperation; motivation to get things done; ability to express ideas logically and coherently; positive attitude; ability to overcome obstacles; assumes full responsibility; utilize the appropriate resources to solve problems; reacts quickly to unforeseen events
  • You are a good judgment and ability to innovate will make you an excellent candidate
61

Manager, Quality Resume Examples & Samples

  • Achieve the required product quality performance by reinforcing and implementing the quality management system
  • Ensure functional role is integrated into Business Unit resulting in a one-team approach
  • University degree in a technical, quality, or program management discipline is preferred
  • You have minimum five (5) years management experience in Quality (Aviation experience preferred)
  • Valid AME license or equivalent would be an asset
  • Knowledge in working with unions and collective agreements would be an asset
  • You have a strong interpersonal and negotiation skills
  • You have a successful candidate possesses the following: ethics, integrity and honesty; respect for others; cooperation; motivation to get things done; ability to express ideas logically and coherently; positive attitude; ability to overcome obstacles; assumes full responsibility; utilize the appropriate resources to solve problems; reacts quickly to unforeseen events
  • You have a good judgment and ability to innovate will make you an excellent candidate
62

Manager, Quality, Auburn Resume Examples & Samples

  • Three to five years in quality management, accreditation and licensure, process improvement in an acute care hospital setting, and oversight of infection control is required
  • Three to five years of applicable experience including managing CQI systems for medical staff and hospital staff, responding to patient grievances, and processing of legal claims is required
  • Three to five years of demonstrated ability to analyze clinical data and recommend/implement appropriate action plans is required
  • Three to five years of prior experience in The Joint Commission Survey preparation is required
  • Three to five years of experience in clinical outcomes and effectiveness initiatives including review of hospital experience, comparison to standards/norms/targets, and development and implementation of programs to improve outcomes is required
  • Oversight of, or active participation in Risk Management duties is preferred
  • Oversight of, or active participation in Medical Staff Office duties is preferred
  • Lean methodology experience is preferred
  • Supervision, organization, setting priorities within a healthcare setting, attention to detail, self-direction, high degree of independence, judgment and discretion, teaching ability
  • Effective oral and written communication skills, including effective communication of data
  • Tact, diplomacy, and the ability to work with individuals in all levels of hospital and medical staff organization
  • Ability to lead, as well as serve as a member on a diverse team
  • Must be computer literate, especially in spreadsheet/graphics and database management
  • The incumbent must have demonstrated abilities to professionally handle public contact, and highly sensitive and confidential information
63

Manager Quality / Project Mgmt-transplant Resume Examples & Samples

  • Multi-project planning and management skills
  • Advanced oral and written communication skills
  • Ability to work collaboratively with employees at all levels of the organization
  • Manages performance improvement activities for Transplant Service Line consistent with CMS Focused QAPI Conditions of Participation (CoP)
  • Ensures optimal compliance with accreditation and regulatory agencies' requirements (JCAHO, CMS, CMS F-QAPI, and UNOS) by routinely analyzing accreditation standards, regulatory rules and Children's policies. Drives compliance and develops and implements activities and policies/procedures designed to meet requirements of these agencies
  • Drives, develops, and coordinates an ongoing multifaceted quality assessment program as set forth by the CMS Focused-QAPI CoP’s
  • Monitors operational processes to ensure safe, efficient and quality performance standards for patients, visitors and employees. Supports and participates in continuous assessment and improvement of the quality of care and transplant services provided
  • Manages the orientation, competency assessment and mandatory education for Transplant Program staff in coordination with clinical educators. Facilitates a patient education program for transplant services
  • Directs projects and project teams related to the implementation of the Transplant Strategic Plan, operational improvement of the department, and accomplishment of service line goals. Includes evaluating clinical, research and financial data, core processes, and infrastructure related to projects and making recommendations, developing implementation plans and managing the implementation
  • Completes all assigned projects within specified time frames meeting all deliverables
  • Supports Transplant Services Director in developing and implementing marketing and public relations plans
  • Supports customer service activities for Transplant Services
  • Works collaboratively with internal and external resources
64

Manager, Quality Resume Examples & Samples

  • This role will develop and provide leadership on all aspects of Sanitation, in the areas of Quality Systems, Sanitation standards and policies, Operations effectiveness and efficiency including External Manufacturers/Suppliers, BU product/process development, and both equipment and infrastructure design. Drive continuous improvement in all sanitation programs and provide technical support to the plant for continuous improvement execution
  • Lead development and implementation of a strategic plan that sets sanitation direction and performs audits for areas including sanitation equipment preventative maintenance programs, sanitary design, pest control, GMPs, utilities standards, extraneous materials. Take ownership of programs at the proper levels within assigned facilities
  • Lead on new sanitation technology investigations, and efficiency verification for right fit to right process
  • Deliver continuous improvement through innovation, benchmarking, sanitation effectiveness and efficiency evaluations and leveraging cross-BU collaboration
  • Support SSMT by leading root cause identification and appropriate plant and network corrective actions
  • Provides technical expertise on sanitary design for capital projects
  • Inform and escalate and provide support as needed for any food safety/quality issues involving plants, vendors or supplier related
  • Provide technical expertise for zoning and environmental monitoring (PEM and non-PEM)
  • People development through training, technical skill development, audit readiness assessments and mentoring of in-plant personnel
  • Represent Kraft Foods and influence various stakeholders (i.e. AMI, GMA, regulators) of the US and Canadian Food Industry from meat to dry goods to raise the bar on sanitation standards
  • BS Food Science/Engineering/Chemistry or other relevant sciences
  • 7-10 years of experience quality and/or sanitation management experience in multiple product(meat or cheese) plant, corporate experience a plus
  • Functional understanding of food processing equipment
  • Sanitary design principles
  • CI/IL6S
  • Root cause analysis with food safety and product quality events
  • Ability to troubleshoot by observing, analyzing data and identifying gaps and corrective actions
65

Manager Quality / Project Mgmt-neurosciences Resume Examples & Samples

  • Licensed RN with experience in clinical data analysis and outcomes
  • Master’s degree in Life Science, Healthcare Management, Business, or related field
  • Has worked with Qlikview, Epic and comfortable with advanced functions in MS Excel
  • Demonstrated leadership skills in facilitating and leading cross-functional teams and working collaboratively with groups or teams
  • Proven aptitude for problem-solving and strategic thinking
  • Directs projects and project teams related to the implementation of the Neurosciences Strategic Plan, operational improvement of the department, and accomplishment of service line goals. Includes evaluating clinical, research and financial data, core processes, and infrastructure related to projects and making recommendations, developing implementation plans and managing the implementation
  • Supports Neurosciences Director in developing and implementing marketing and public relations plans
  • Supports customer service activities for Neurosciences
  • Manages performance improvement activities for Neurosciences Service Line to include: Neurology, Neurophysiology, Neurosurgery, Neuropsychology
  • Ensures optimal compliance with accreditation and regulatory agencies' requirements by routinely analyzing accreditation standards, regulatory rules and Children's policies. Drives compliance and develops and implements activities and policies/procedures designed to meet requirements of these agencies
  • Drives, develops, and coordinates an ongoing multifaceted quality assessment program
  • Monitors operational processes to ensure safe, efficient and quality performance standards for patients, visitors and employees. Supports and participates in continuous assessment and improvement of the quality of care and Neuro services provided
  • Manages the orientation, competency assessment and mandatory education for staff in coordination with clinical educators. Facilitates a patient education program for transplant services
66

Manager, Quality Resume Examples & Samples

  • Bachelor’s Degree and 3 years leadership experience OR minimum of 5 years leadership experience in the discipline OR Master’s degree and no experience
  • Registered Nurse, clinical licensure preferred
  • Nationally recognized quality-related certification (ie:. CPHQ, PMP, CJCP, CPPS) preferred
  • Working knowledge of National Quality Forum (NQF), Agency for Healthcare Research and Quality (AHRQ), Institutes for Healthcare Improvement (IHI) safety indicators, serious reporting events, safe medical practices, and Centers for Medicare and Medicaid Services (CMS) quality measures helpful
  • Required minimum of 3 years leadership experience with a Bachelor’s degree OR 5 years leadership experience in the discipline without a Bachelor’s degree
  • Prior experience within a healthcare setting highly preferred
  • Experience in quality improvement principles, performance improvement methodology, project management and change management preferred
  • Knowledge of regulatory and accrediting standards and Medical Staff Office preferred
  • Patient safety experience and work with High Reliability Organizations / Systems a plus
67

Manager Quality Controls Resume Examples & Samples

  • Analyze the fundamental components of problems and communicate the correct course of action to the team and the resolution to the field
  • Develop and implement changes that improve overall store operations processes that are likely to add value to the stores' bottom line. Manage/drive core store operations projects and/or process improvements
  • Manage day to day processes related to their areas of responsibility. Create and maintain project work plans
  • Manage issues and roadblocks that arise related to their area of responsibility
  • Respond proactively to unanticipated store needs arising out of a variety of inputs. Manage action steps necessary for successful execution of both strategic projects/initiatives and process improvement
  • Communicate effectively and build strong, effective partnerships with the field/stores and throughout The Home Depot
  • Prepare and deliver high-level insights and recommendations based on multiple analyses of industry/ business, competitive landscape, consumer data for area of expertise
  • Provide guidance and training specific to area of expertise. Assist in collaborating findings from data and making verbal/written recommendations. Demonstrate proficiency/understanding of specific processes
  • Maintain knowledge base regarding specific operations and processes within store operations
  • Responsible for appropriate selection, terminations, performance appraisal and professional development of support team (Business Analysts)
  • Strong business, functional and/or store knowledge for their area of responsibility
  • Leadership and management experience preferred
  • Strong operations, retail and/or field experience required
  • Ability to partner/communicate well with the field/stores
  • High sense of urgency in responding to field needs
  • Strong big picture; strategic thinking skills
  • Strong quantitative skills such as statistics and data analysis
68

Manager, Quality Investigation Resume Examples & Samples

  • Directly supervise the work activities of employees engaged in customer complaint handling and investigations (Internal and External) and documentation processing across multiple locations
  • Assure that controls are in place to effectively and accurately process customer complaints and Investigations
  • Provide support to the functional groups within the company on customer complaints and investigations. Interface effectively with Engineering, Manufacturing, Regulatory Affairs and other technical functions
  • Ensure that all investigations are thorough, accurate and being conducted in a timely manner. Ensure that investigation files are properly maintained in accordance with company policies and procedures. Performs file review and closeout of individual investigations
  • Provide support during regulatory inspections and customer audits
  • Assess individual complaints for regulatory reporting requirements. Assure that regulatory reports (ADEs, MDR or MDV) are filed as required
  • Monitor complaint activity across multiple sites. Prepare and present trend reports to management. Communicate product complaint information internally with sales force, marketing functions, and operations, and externally with customers and regulatory bodies, where required, both verbally and in writing
  • Internally support the Manufacturing Business Units to provide quality engineering support to adverse quality trends or continuous improvement projects
  • Provide guidance and prioritize projects and workload for the quality engineering staff
  • Assure all investigations from either internal or external sources are thoroughly investigated to root cause and trended across data streams in order to assess effectiveness of corrective and preventive actions
  • Provide / formulate product disposition or other actions related to product nonconformance and field performance issues
  • Provide risk assessment on product nonconformance and field performance issues
  • Review Internal Audit (IA), Deviation, Out of Specification (OOS), and Supplier Corrective Action Notification (SCAN) responding reports
  • Track and monitor metrics related to the customer complaint process and develop and implement programs designed to increase department and company employee awareness
  • Responsible for training, development, motivating and counseling of subordinate staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Effectively communicate a variety of personnel actions; e.g., employment, termination, performance and salary reviews, disciplinary actions, scheduling and/or approving overtime
  • Ensure personal training in accordance with department training matrix
  • Provide input to budget development and ensure operations within approved department budget. Actively contribute to cost control methods
  • Performs other related duties as required by management
  • Knowledge of quality policies, FDA Regulations and ISO Standards for Pharmaceutical (21CFR 210 & 211) and Medical Device Quality System Regulations (21CFR 820), ISO 13485 and MDD
  • Mastery of customer complaint handling requirements
  • Must be able to work with all functional groups
  • Strict attention to detail required. Problem detection ability a must
  • Ability to act effectively as a team member to resolve problems
  • Ability to effectively work with all functional groups
  • Interface with a wide variety of disciplines to evaluate applicability of existing methods
  • Proficient in the use of computers including a wide variety of word processing and spreadsheet software packages
  • Demonstrated customer relations skills
  • Sufficient human relations skills to effectively staff and manage relevant personnel and functions to assure that company goals and responsibilities are met
  • Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company
  • Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time
  • Ability to investigate and analyze technical and regulatory issues
  • Knowledge in Industrial Statistic and its application to Pharmaceutical Manufacturing, Quality Control, and SPC
  • 4 - 8 years professional experience with at least 2 years of supervisor experience
  • Bachelor's Degree required, degree in Engineering or Science strongly preferred
  • Minimum 5 years experience in quality systems documentation & administering FDA requirements
  • Advanced degree or certifications
69

Manager Quality Resume Examples & Samples

  • Bachelor’s degree in related field required or equivalent combination of education and 5 years’ experience specifically related to Quality or Operations Improvement
  • Minimum 2 years supervisory/management experience required, preferably in the ambulatory setting
  • Lean Six Sigma Green Belt Certification preferred
  • Proficient in Microsoft Office and presentation skills
  • Must possess knowledge of population health methodologies, metrics, and measurements (HEDIS, USPSTF, NCQA, etc)
  • Demonstrates knowledge of third party payer policies, CMS standards, and regulatory billing compliance standards, both regionally and nationally
  • Analytical ability required to gather data and analyze data, decide on conformity based on predetermined criteria, identify problems and refer for resolution
  • Excellent Lean/Process Improvement & Quality Improvement skills
  • Adept at creative problem-solving, negotiating conflict, and collaborating with others
  • Demonstrates insight, judgment, and clinically sound risk-taking
  • Ability to build and maintain effective communication and working relationships with staff and physicians
  • Performs skills and competencies as defined in orientation checklist and annual departmental competency checklist if applicable
  • Demonstrates and maintains competencies specific to patient population served
70

Manager, Quality & Access Resume Examples & Samples

  • Support member and provider outreach communication goals by playing a leadership role in the management of external relationships such as print vendors and client relationships
  • Accomplish departmental goals by assigning and overseeing the activities of the member advocate staff and by proactively communicating to the director issues, which may prevent accomplishment of departmental goals
  • Supervising the staffing of member advocate resources and projects by working with senior management
  • Comfortable in leadership role to develop advertising and direct mail strategies, proposals, outreach for key audiences
  • Develop and supervise action plan for all projects including the development of materials and adhere to established processes for review and coordinating printing and distribution
  • Organize and track key information and documents
  • Work with other departments to ensure agreed upon deliverables are met
  • Evaluate partnerships by using strategic thinking, direction, capabilities and results, and recommend and implement improvements
  • Manage outreach programs in New York and New Jersey by understanding performance metrics including but not limited to, QARR, HEDIS, CMS-416, cost implications of care, and state incentives per client
  • Develop outreach plan and ensure successful execution as evidenced by improvements in performance metrics
  • Lead development of budget to finance interventions designed to improve access to care, performance metrics and quality outcomes
  • For all markets, understand financial impact of increases in access as it correlates to cost of care. Be able to demonstrate cost/benefit analysis and options for specific markets, and for general capabilities as related to sales and business development
  • Provide strategies and recommendations to increase access to care within stringent budgets
  • Develop strategies that manifest DentaQuest’s oral health mission for members that are tangible both at the national level, as well as within specific states/markets
  • Provide Project Management to cross functional teams to assure successful implementations of new business as related to outreach and access to care programs
  • Create and improve implementation workflows between departments to ensure client deliverables relating to access to care and/or quality are being met, according to the contract
  • Develop and maintain relationships with several key contacts in various healthcare and community-based organizations
  • Represent DentaQuest at health fairs, conferences and advisory meetings
  • Foster an environment of teamwork by participating in and leading teambuilding activities
  • Performance management of staff. This is including but not limited to
  • Recruiting and hiring process
  • Draft and deliver corrective action plans as needed
  • Preparation and presentation of performance and wage evaluations, including development of goals, ensuring compliance with DentaQuest policies
  • Manage time off request and ensure adherence to DentaQuest policy for PTO usage and attendance
  • Monitor productivity and workflow
  • Coordinating and implementing appropriate strategies for motivating team members
  • Conduct regular staff meetings
  • Identify and create workflow efficiencies
  • College degree, preferred
  • Five proficiencies and leadership attributes, advanced skills sets related to planning and project and resource management
  • Manage projects with minimal supervision
  • Strong organizational and verbal communication skills and can articulate concepts, project plans and statuses to key internal and external stakeholders both verbally and in writing
  • Strong experience handling multiple projects and priorities concurrently
  • Ability to work effectively both independently and as part of a team
  • Excellent organizational skills and strong attention to details and deadlines
  • Strong experience working with/managing graphic designers and printers
  • Ability to make appropriate decisions
  • Ability to present to professionals – clients, colleagues, senior leaders
  • Excellent communication skills: written, verbal and interpersonal
  • Ability to work well with others at all levels of the organization
  • Ability to identify and escalate critical conditions
  • Strong computer skills including Microsoft Office applications, and general reporting software
  • Energetic and resourceful
  • A minimum of 3 years’ experience working in an outreach, research, public health role
  • Experience with insurance and/or service industry a plus, in addition to managing projects and resources
  • In accordance with DentaQuest’s Compliance Plan, employee must conduct DQ business in accordance with applicable laws, regulations, professional standards and ethical standards and report potential compliance or ethical issues to manager or DQ’s Compliance Officer. **DentaQuest’s Affirmative Action Program affirms our commitment to make reasonable accommodation to the known physical or mental limitation of otherwise-qualified individuals with disabilities or special disabled veterans, unless the accommodation would impose an undue hardship on the operation of our business. Please see Human Resources for additional information regarding this Program
71

Manager, Quality Interface Resume Examples & Samples

  • Bachelor Degree or Postgraduate Degree in Engineering or related fields
  • At least 3 years of experience in Quality Assurance and Quality Control preferably in Watch & Jewelry industry
  • Good understanding in Quality Process
  • Analytic skills to define root cause for quality problem
  • Good leadership & management skills
  • Proficiency in English, good in report writing
  • Self-discipline and result driven
  • Proactive attitude and team player
72

Manager, Quality Resume Examples & Samples

  • Promote a culture of continuous improvement and prevention. Promote the use of proactive Quality planning tools such as SPC, FMEAs, Control Plans, etc. as part of the prevention process. Coordinate activities of Manufacturing and Engineering to ensure the effective introduction of new/improved products, processes, and materials. Utilize process/product audits, customer feedback, and other tools to drive continuous improvement in the operation and recommend appropriate changes to Products and/or Services
  • Establish criteria, metrics and goals to demonstrate quality effectiveness in the areas of production efficiency, yield improvement , scrap reduction and customer satisfaction
  • Maintain a Quality information system that communicates key quality related information to site management and product team members. Reports should be timely, thorough, and provide sufficient analysis or recommendations that appropriate actions may be taken
  • Participate as an active and contributing member of the appropriate Global Quality Management and Product Team(s) to insure that the product line and Corporate Quality standards are achieved. Benchmark best practice and support other CommScope locations if required
  • Promote value through continuous improvement of our products, services and business processes
  • Promote a culture of Compliance, change control, continuous improvement and prevention. Promote the use of proactive Quality Planning Tools such as 6 Sigma, SPC, FMEAs, Control Plans, etc. as part of the process
  • Coordinate Quality activities within the site to ensure the effective introduction of new/improved products, processes, and materials in line with Change Management requirements. Utilize process/product audits, customer feedback, and other tools to drive continuous improvement in the operation and recommend appropriate changes to Products and/or Services
  • Coordinates quality initiatives to meet business unit objectives and assure global consistency, and to assure the quality system meets or exceeds internal and external customer needs and expectations
  • Oversees process development and improvement of established quality system, and champions’ continuous improvement in areas and locations of responsibility
  • Minimum of a Bachelor Degree in Engineering or a related Technical field required with 5-8 years experience
  • Prefer previous experience in the Quality Assurance field
  • Working knowledge of basic Quality tools such as MiniTab, SPC, FMEA, Control Plans, Root Cause Analysis, Poke Yoke, etc. required
  • Must have working knowledge of 6 Sigma. Master Black Belt certification a plus
  • Must have proven experience or ability to lead technically trained employees, including degreed engineers
  • Must have demonstrated Word Processing, Database and Spreadsheet PC skills
  • Excellent communication skills and ability to summarize significant amounts of data into easily understood reports with appropriate recommendations required
  • Ability to interact comfortably at all levels within the organization and to facilitate customer visits when required
  • Must have ability and desire to drive change where required
73

Manager, Quality Evaluations & Insights Resume Examples & Samples

  • Function as a consultant and business partner to other groups within ADP
  • At least 1 years of people leadership experience
  • Ability to demonstrate learning agility and critical thinking skills and apply basic concepts in new situations
74

Manager, Quality Resume Examples & Samples

  • Manage the team to achieve Quality productivity goals and contractual requirements
  • Facilitate and/or participate in client meetings and internal and client calibration sessions, as required
  • Provide effective personnel coaching and development to achieve and improve performance
  • Facilitate and maintain internal and client reporting cadence for quality functions
  • Drive and facilitate performance analysis, identify trends, and make recommendations to drive ongoing performance improvements
  • Support management focus on review of key drivers, metrics, and operational processes that drive balanced scorecard and account profitability goals
  • Support transition and implementation of new projects, as required
  • Perform team inspections, as required, to ensure we remain within compliance with requirements
  • College degree preferred. Educational requirement may be substituted with equivalent industry-related business experience
  • High School Diploma or GED required
  • Minimum 3 years management experience with 1 -2 years being in call center management
  • Minimum 1-2 year call center experience
  • Working knowledge of applicable customer contact systems, monitoring systems, and reporting software / applications
  • Analytical and process improvement skills
  • Effective feedback, coaching, and motivation skills
  • Strong interpersonal skills / Performance-oriented
  • Sound organizational and team-building skills
  • Ability to work and adapt in a dynamic and fast-paced environment
  • Proficiency with MS Office Products - Excel, PowerPoint, and Word applications
  • Champion for high employee morale and an advocate to support positive change in our call center culture
75

Manager Quality Culture Resume Examples & Samples

  • Assist in setting the strategy and programs for implementing quality culture in organizations, in close collaboration with the QM, BRQC and R&D stakeholders and in alignment with Pharma and Enterprise Strategy for Quality Culture Implementation
  • Will be serving as a champion to key business partners and, stakeholders and as a conduit between business partners, quality groups, and governance to enable and promote a quality culture with focus on quality and compliance accountability
  • Work with the relevant stakeholders to develop and coordinate departmental QM expertise training and development programs, as well as change management strategies that will enable the QM staff to deliver state of the art services. He/she will coordinate and support cross-functional learning events, communication and other initiatives
  • Coordinate and facilitate Quality Culture Management Workshops, and will support the organization of Employee Workshops including follow up with Business Partners, to support the roll out of a sustainable Quality Culture in BRQC and R&D Business Partners
76

Manager, Quality Ratings Resume Examples & Samples

  • Develops and refines short- and long-term strategies to improve performance on quality ratings programs that are aligned with Healthfirst’s overall corporate strategy. Monitors status of current and projected performance on Quality Ratings and reports out to senior leadership and the health plan’s Quality Committees
  • Collaborates with colleagues across the organization to identify and vet data-driven opportunities to improve performance on quality ratings programs. Creates, manages and evaluates project plans and work plans. Reviews data to evaluate impact of interventions and to drive continuous performance improvement
  • Acts as subject matter expert on assigned Healthfirst Quality Ratings programs, including program and measure specification proposals / changes. Communicates with business owners and senior leaders to provide information on proposed changes and their impact to Healthfirst
  • Drafts and refines comments to regulatory agencies, measurement bodies, coalitions, and other industry groups about Quality Ratings programs, seeking input from stakeholders across the organization. Collaborates with external groups and experts about Quality Ratings program changes, best practices, and other relevant topics
  • Champions culture of quality by supporting workgroups in improving processes and operations, researching and communicating industry best practices, and recognizing teams and individuals for their contributions to quality
  • Effectively manages staff and team performance, supporting their professional growth and building the next generation of Healthfirst leadership
  • Healthcare experience associated with population health outcomes, quality improvement, or policy
  • Proficiency in Microsoft Office – daily use of Outlook, the ability to create polished Power Point presentations for a range of audiences, intermediate to advanced Excel skills, intermediate Word skills
  • Excellent written and oral communication skills. Experience presenting senior leaders within or outside of one’s place of employment
  • Experience analyzing data and making data-driven recommendations for quality improvement
  • Experience leading cross-functional work groups
  • Master's degree in Public Health or Business Administration
  • Experience working with a hospital, health insurance company, or healthcare focused government agency or non-profit (e.g. DOH)
  • Strong leadership skills with the ability to manage up and across multiple departments of a large organization
  • Experience with complex and high-impact projects and programs. Proven ability to handle multiple projects simultaneously and adjust to changes quickly while meeting deadlines
  • Strong problem solving and effective decision making skills. Ability to exercise sound judgment
  • Ability to work independently in a fast paced environment
  • Supervisory or team lead experience. Ability to train, coach and mentor staff
77

Manager Quality Resume Examples & Samples

  • Lead the BU’s effort to upgrade current SQM practices to improve supplier and supplied item qualification and surveillance activities to the reduce occurrences and risks of product affecting supplier excursions. Upgrade SQM policies and practices to accommodate tiered suppliers and supplied items suitable to business need requirements such as automotive, key and commodity supplier types. This includes
  • Demonstrate abilities to lead in problem solving/countermeasure events where quality issues are diagnosed, discussed, and resolved
  • Lead and drive the organization using widely accepted quality techniques such as the 8D problem solving, 5 Whys, Kaizen events, etc
  • Adept at challenging participants to provide timely resolution to quality issues
  • Adept at dealing with quality issues by written documentation, conference calls, or in person
  • Adept with working with other departments to develop plans, presentations and other materials as may be necessary to resolve quality issues and in a timely manner
  • Adept at developing project and implementation plans, be able to drive progress within and across departments to meet objectives per the plan or defined timelines
  • Must be able to provide timely communication across the organization on quality related matters and be willing and able to escalate those issues requiring immediate attention
  • Minimum of a Bachelor’s degree in a technical field such as Electrical Engineering, Mechanical Engineering, and/or Industrial Engineering; and/or suitable work experience
  • Demonstrated experience in the design and implementation of Supplier Quality Managements systems
  • The candidate should be familiar with all PPAP elements such that he/she can prepare, review and verify, coach and/or train the organization on their effective use
  • Preferred Certified Lead Auditor to IATF 16949
  • Preferred Lean/Six Sigma certification or equivalent work experience or company certification
  • Demonstrated knowledge of quality assurance and reliability methods and improvement tools
  • Experience in the automotive industry that demonstrates working knowledge for quality requirements, protocols and automotive customer’s expectations is desired
  • Preferred understanding of fundamental Quality and Manufacturing monitoring software, such as SPC software, JMP or Minitab, MS Project, and MS Access
  • 5 years experience as a Supplier Quality Engineer/Supplier Quality Manager who can demonstrate effectively leading an organization to improvement performance using quality methods and approaches
  • Expertise with semiconductor design and manufacturing processes
  • US citizen or Green card holder
78

Manager, Quality Resume Examples & Samples

  • Our manager will supervise and lead quality personnel on professional, personnel issues, and career development opportunities
  • You will provide direction to personnel on topics such as: complaint reporting, FDA requests for additional information, field action assessment and execution, electronic complaint management system implementation and validation
  • Identifying the opportunities for continuous improvement of quality systems impacting post market surveillance, design controls, and CAPA, field actions
  • You will also support internal audits and initiates activities to support the improvement activities
  • Routinely you will present data, analyses, and recommendations to partners at the business to ensure compliance and customer happiness
  • You will represent our post management process to national regulatory agencies, during audits, to demonstrate compliance
  • We want you to meet with department leaders to develop long term vision, objectives and goals for the organization
79

Manager Quality Assuranceat CDW Careers Resume Examples & Samples

  •  10 years of related IT job experience
  •  5 years of management experience
  •  Bachelors degree in Information Systems, Computer Science, a related field, or related job experience
  •  Working knowledge or experience in automated and performance testing tools and strategies
  •  Ability to effectively collaborate and communicate with internal and external stakeholders, including
  • Senior Leadership
  •  Demonstrated ability to define problems, collect data, establishes facts, and draw valid conclusions
  •  Demonstrated ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
  •  Excellent written and verbal communication skills
  •  Ability to write business correspondence and reports, systems documentation, and procedure manuals
80

Assistant Manager, Quality Enhancement Resume Examples & Samples

  • Monitor call and analysis the call pattern to identify improvement area about TMRs’ selling skill
  • Evaluate telephone manner, products and guidelines of telemarketers’ calls and provide effective feedback for uplifting sales quality
  • Work close with training team to develop appropriate tactics and activities to fill the gaps, like call coaching, call sharing, hand-holding training, classroom training, with an aim to support the sales team to achieve good performance
  • Supervise and coach junior staff
  • Form 5 and above or related discipline
  • Minimum 5 years of working experience, preferably in insurance , banking or telemarketing industry
  • Good interpersonal and communication skills in both written and verbal
  • A good team player with positive working attitude
  • Proactive, open-minded, eager to learn and creative
81

Manager Quality Resume Examples & Samples

  • Planning and program performance addressing cost, schedule, technical performance, and quality of a work package, subsystem, or related group of work packages on a large system development-type contract or full responsibility for all aspects of program performance on a large delivery order or mid-size technical services-type contract
  • Assignments are received in objective oriented terms and provides direction to subordinates based on general policies and management guidance. Work is reviewed for adequacy in meeting objectives
  • Decision making, oversees projects, and task assigned to the organizational group performed by non-exempt and/or exempt employees. Becomes involved only when required to assist in meeting schedules or to resolve technical or operational problems. May accomplish results through lower level supervisor or exempt employees
  • Executes department procedures that typically affect individual employees within own department. Policy management: Interprets and executes policies and procedures that typically affect subordinate organizational units. Recommends modifications to operating policies
  • Ensures that projects are completed on schedule and within budget. Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional time, human resources and funds
  • Accomplishes results through lower-level subordinate supervisors or through experienced exempt employees who exercise significant latitude and independence in their assignments. Often head a centralized functional activity
  • Functions as an advisor to unit regarding tasks, projects, and operations. Becomes actively involved in daily operations only when required to meet schedules or to resolve complex problems
  • Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling or specific phases of projects or contracts. Conducts briefings and participates in technical meetings for internal external representatives concerning specifics operations
  • Bachelor's degree with a minimum of 5 years of Aircraft Manufacturing/Quality experience
  • Experience leading teams and managing employees
  • Experience in the requirements/processes for manufacturing/engineering
  • Ability to obtain and maintain a D.O.D. Secret Clearance. U.S. Citizenship is required
  • Manages competing demands; Able to deal with frequent change, or unexpected events
  • Excellent communication and team building skills
  • Prioritizes and plans work activities of self and others
  • Proficient in continuous improvement processes and tools, i.e., Six Sigma, SPC, KC Variation Management