Quality Management System Resume Samples
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Quality Management System Resume Samples
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FR
F Ryan
Filiberto
Ryan
93118 McLaughlin Islands
San Francisco
CA
+1 (555) 195 9684
93118 McLaughlin Islands
San Francisco
CA
Phone
p
+1 (555) 195 9684
Experience
Experience
New York, NY
Quality Management System Auditor
New York, NY
Brakus-Bayer
New York, NY
Quality Management System Auditor
- Facilitates Contract Management Office (CMO) Management Council activities
- Collaborates with audit clients and action owners to provide Root Cause Analysis (RCA) guidance and ensure effective Corrective Action Plans (CAP) development
- Develops and executes audit plans
- Execute audits including opening and closing meetings
- Manage Corrective Actions to closure
- Cultivates productive relationships with Defense Contract Management Agency (DCMA) representatives and managing DCMA Corrective Action Requests (CAR)
- Performs audit follow-up activity to verify effectiveness of corrective actions and implementation of preventive actions
Dallas, TX
Quality Management System Manager
Dallas, TX
Morar, Turcotte and Ledner
Dallas, TX
Quality Management System Manager
- Ensures timely reporting to the management of the entity and to Quality management for risk prevention purposes
- Supports change management, and provides support and guidance to operational teams and process owners (GPOs/CPOs)
- Makes sure that the management system is effectively implemented
- Lead the Quality Management System harmonization between the division’s sites
- Train personnel on Quality Management System related topics
- Takes part in the Management System Steering Committee (MSSC ), the Management System Peer Review (MSPR ) and the Management System Control Board (MSCB ), and makes sure that feedback is provided
- Organizational fit for the Thales culture, that is, exhibit the Thales values of Compliance, Respect, Innovation, Responsibility, Teamwork
present
Dallas, TX
Continuous Improvement & Quality Management System Manager
Dallas, TX
Auer-Wisoky
present
Dallas, TX
Continuous Improvement & Quality Management System Manager
present
- Systematically apply coaching techniques and tools to support managers and team members in improving their performance
- Ensure consistency of process development with Business Process Owners/Process Owners wide process development
- Manage and support the evolution, improvement and deployment of BT Integrated Business Processes for the area of responsibility (site/BU/region/division)
- Coach the senior management of the site in their continuous improvement transformation both from a behavior and tool aspect
- Lead the development & implementation of the continuous improvement system on site
- Managing and support to all functions for the management of corrective and preventive actions, as well as the consolidation and reporting of it
- Act as the Change Agent in the transformation process introducing the continuous improvement culture
Education
Education
Bachelor’s Degree in Nursing
Bachelor’s Degree in Nursing
Temple University
Bachelor’s Degree in Nursing
Skills
Skills
- Capable of building strong relationships with the functional Business leaders in order to effect change
- Strong situational leadership skills to influence all levels of the organization (Senior leaders to operators)
- Excellent planning and organizational skills
- Hands-on and results oriented with a strong work ethic and sense of personal responsibility
- Strong interpersonal and communication skills
- Self-starter to lead change and make independent and informed decisions
- Intermediate to advanced expertise with Excel, PowerPoint, Outlook, Word, and Visio
15 Quality Management System resume templates
Read our complete resume writing guides
1
Quality Management System Leader Resume Examples & Samples
- 55% QMS Standards (Procedural Documentation and Development)
- Bachelor's degree in a science, business or technical related field is required
- Minimum 8 years in R&D or Quality Assurance in a Pharmaceutical environment supporting GxP system is required
- Training development and deployment experience preferred
- Knowledge of or experience with six sigma or Lean methodology is desirable
- Knowledge of US, EU, ICH regulations, guidelines and requirements
- Knowledge and/or awareness of applicable regulations and guidance governing our business
- Knowledge of implementation and management of quality management systems (QMS)
- Experience with technology systems supporting QMS
- Strong people leadership capabilities
- Current on innovative training approaches and training technology including adult learning research
- Demonstrated record of initiative and change management
- Strong collaborative team player with a positive attitude to work successfully within a diverse and dynamic cross functional team
- Self-motivation and ability to work under limited supervision and direction
- Strong judgment and decision making abilities
- Excellent written and oral communication skills, the ability to interact and communicate with individuals at all levels of the organization
- Must be able to work in a fast paced environment with demonstrated ability to handle multiple competing tasks and demands, including the ability to work independently, take initiative, and complete tasks to deadlines
2
Quality Management System Lead Resume Examples & Samples
- Support Software Solutions functional departments in define and development of processes
- Coordinate with the functions and unit quality team to roll out and implementation of processes, piloting when necessary
- Manage the SWS’s Business Management System according to the GE Grid Solutions and to GE corporate requirements
- Periodic appraisals of the efficacy of the process compliancy
- Update the organization process capability; benchmark with industries best practices (CMMI/ISO9003) including GE Digital
- Manage plans for internal and external audits in accordance with GE SWS requirements and ensure execution conforms to plan
- Maintain a corrective/preventive action program, inclusive of monitoring and evaluating open actions, receiving, and reviewing responses, working with functional departments for timely completion and verification of effectiveness and periodic reporting and metric tracking
- Acts as the Management Representative for the company’s ISO 9001:2008 certification and champion the transition to ISO9001:2015 when appropriate
- Oversees audits of existing and new ISO procedures for compliance based on ISO requirements and audit history
- Schedule and oversee units/regions-wise training to improve product quality/quality awareness
- Coordinate, schedule, and assign internal ISO process audits for all departments
- Report ongoing ISO activity status, schedules, quality objectives, metrics, etc. to periodic formal meetings
- Coordinate and administer third party quality audits, inclusive of schedules, communication, reports, and tracking follow-up actions
- Drive the implementation of ISO 27000
- 5 years’ experience in Quality / in Operations or in a Support Function preferably in software industry
- Familiarity with product Quality and Reliability methodologies including, MTBF, FMEA, Causal Effects Analysis, 8D, 5 Whys etc
- 6 Sigma Green/Black Belt desirable
- Demonstration of leading continuous improvement actions with strong portfolio and project management
- Ability to work effectively across functions, prior experience of developing and leading a team or significant multidisciplinary project
- Proven mentoring and coaching abilities, demonstrated ability to motivate & inspire others
- Proven facilitation and team leading skills
- Excellent written/oral communication and interpersonal skills, customer focused, enthusiastic. Ability to coach and to shape a vision and communicate it with enthusiasm
- Demonstrates a high degree of personal and professional integrity
- Understand key drivers of Project Delivery, Product Quality, Product Development and Delivery Life Cycle
- Strong analytical skills with ability to identify and explain critical issues. Six sigma/lean/fast works awareness is preferred
- Knowledge of ISO 9001 philosophy and principles
- Experience of management and of leading by influence within a matrix organization
- Must be able to handle multiple projects simultaneously within stringent time constraints, requires discretion and independent judgment, and the ability to maintain a good working relationship with all co-workers, stakeholders and clients
3
Senior Manager of Global Quality Management System Resume Examples & Samples
- Define, develop and deploy Quality Management System requirements across the organization
- Planning and administration of Quality Management System audits for North American locations (e.g. San Jose, Richmond, Austin) at regular intervals in compliance with SunPower Corporation documentation and international standards
- Coordination with Global QMS contacts on audit planning to prevent redundancy of audits
- Lead a process approach based internal audits in North America locations. Communicate audit plans ahead of time and ensure smooth conducting of audits with minimal or no interruption to business
- Ensure timely release of audit reports and issuance of value added findings
- Work closely with process owners to ensure all audit findings are addressed on time, verified for effectiveness with adequate due diligence
- Ensure prompt closure of both internal and external audit findings. Take actions; collaborate with process owners to apply risk based thinking and prevent recurrences of non-conformances
- Liaise with external calibration service providers. Work closely with measuring and test equipment owners to ensure prompt periodic calibration
- Lead periodic Global QMS meeting, coordinate with Global QMS contacts and manage Global QMS dashboard. Seek out best practices and share with other global locations
- Conduct periodic training on ISO 9001 standards, audit management, SunPower Quality Management system
- Create, build and maintain cross functional network (matrix) of trained quality system auditors across USA locations to support internal quality audits
- Liaise with external registrar for audit logistics, and all related administrative activities
- Plan and administer site Management Review meetings periodically At HQ as required by the SunPower EHSQ Manual
- Work closely with EH &S counterpart for alignment and integration of ISO 9001 processes and documentation with ISO 14001 and OHSAS 18001 management systems
- Lead or support SunPower PSC assessment (Baldrige Model) initiative
- Travel to USA locations frequently and SunPower global locations annually will be required
4
Quality Management System Lead Auditor Resume Examples & Samples
- Review client’s quality management system
- Assess areas of non-conformity related to audited processes
- Verify and document evidence of conformance and non-conformance
- Write comprehensive reports on audit findings and communicate to client
- Assist with corrective action requirements resulting from assessments
- Bachelor’s Degree in Engineering or equivalent experience as a Manager or Supervisor
- Advanced coursework or training in Quality Management Systems
- 10+ years of experience within the quality industry in a professional capacity
- Manufacturing experience in Production, Engineering, and Management Systems
- Knowledge of the principles and practices of manufacturing systems
- Preference will be given to those with advanced working knowledge of industrial systems and related operational controls, monitoring systems, etc. and/or third (3rd) party audit experience
- Ability to travel 90% of the time, including by car and by plane
5
Quality Management System Auditor Resume Examples & Samples
- Bachelor’s degree in Business, Operations Management, System Analysis/Computer Science or related field
- 3+ years of industry experience in product development within high-tech; manufacturing
- Experience conducting internal quality audits and driving CLCA to an established standard such as ISO 9001 within a Product Development Life Cycle and supporting functions
- Strong communication (verbal and written), and interpersonal skills
6
Head of IS / IT Quality Management System Resume Examples & Samples
- Provides leadership, sets strategy, goals and direction for the GLOBE Quality Assurance organization, whilst leading the change of culture in regards to quality management, across our entire organization
- Establishes, reviews, implements and monitors the GLOBE Quality Management Systems (QMS) to assure that IS/IT systems, projects, processes, operations meet both business and regulatory requirements
- Assures that assessment, facilitation and verification of quality standards achieved within GLOBE are all in accordance with the applicable domestic/international regulations, policies and standards
- Develops, manages and follows all internal and external inspections audit program to meet the specified corporate and regulatory quality requirements
- Manages the corrective action and preventive action (CAPA) roadmaps and plans on an effective and integrated fashion with GLOBE’s strategic and operational master plans
- In collaboration with Human Resources and GLOBE relevant departments, assures that an effective IS/IT quality management training program for all related processes and communities is in place
- Manages consistent implementation of regulated processes such as data integrity management, validation, and qualification activities
- Acts as the interface with business, IS/IT partners and health authority to ensure practices are aligned with emerging regulatory expectations and industry requirements
- Leads electronic documentation system strategy, processes and tools which ensure consistency with quality standards and quality of deliverables
- Assess the quality risk in all applicable areas and implement risk mitigation actions
- Master degree in Information Technology, Business Administration, Engineering or equivalent
- At least 10 years’ experience in an IS/IT GxP-related field within a biotechnology or pharmaceutical organization
- Minimum of 5 years managing and leading the IS/IT quality management system and associated teams at the company or corporate level. In global, large scale SAP environments (a plus)
- Knowledge of global quality systems and regulatory requirements and experience in leading Food and Drug Administration (FDA) inspections
- Proven experience of leading large scale IS/IT implementation and change management programs and projects
- Fluent in English (written and verbal communication), French (a plus)
- Strong business mindset with demonstrated ability of conceptual and strategic thinking
7
Senior Quality Management System Specialist Resume Examples & Samples
- Perform QA Review and Approval for Tarrytown related Change Controls, CAPAs, and Deviatons within electronic Quality System
- Lead and document investigations for QAA deviations ensuring identification of root cause and associated corrective/preventive actions
- Provide guidance/training to QAA personnel and customers on investigation/problem solving and root cause analysis techniques
- Partners, interacts and provides guidance to areas such as, but not limited to Technical Training, QAA (Quality Assurance & Auditing), PreClinical and Clinical relative to internal processes and GxP topics. Review and evaluate procedures, systems and processes, which impact business practices and compliance to regulations
- Establish, maintain and improve functional area metrics to assist the continuous improvement of quality and analyze them to assess the effectiveness and performance of associated quality system, e.g. CAPA, Deviations, Change Control, Training, etc. This data is included in regular monthly and quarterly reports to senior executives for the Quality System reviews
- Lead analysis and triage of Regulatory Intelligence (D-RISC) documents for impact to the QAA functional areas
- Assist in/lead continuous improvement projects/initiatives
- Maintains information entered into the QAA information trackers and monitors due dates to ensure visibility and on-time completion for CAPA/Deviations
- Develops and issues weekly QS status communications, action item status updates
- Provides support and interface with customers regarding quality-related issues and procedures
- Author standard operating procedures
- May require 5-10% travel based on business needs
- Knowledge of and experience with Quality Management Systems and Continuous Improvement methodologies (e.g. Lean, Six-sigma). ASQ Green Belt or equivalent desirable
- Additional certifications appropriate to the job will be considered first, I. e Certified Manager of Quality, Engineering, Black Belt, and/or Auditor
- Knowledge of applicable federal, state and local laws, ordinances, statutes, regulations, rules, policies and procedures
- Experience of the overall product development process preferred
- Skilled in motivating, communicating with and instructing/training others, using both technical and non-technical language to explain complex subjects and processes
- Comfortable making decisions independently but demonstrates good judgment in escalating issues to management and QA colleagues
- Has the ability to change the thinking of or gain acceptance of others in sensitive situations
- Ability to negotiate, influence and lead with and without direct line authority, and to engage others and lead an organization through continuous improvement and change is required
- Skill in analyzing information of considerable difficulty and drawing valid conclusions; researching and gathering information related to customers, processes, systems; and managing multiple projects
- Ability to manage multiple tasks and ensure on-time completion
- Working knowledge of electronic quality management systems, MS Word, XL, PPT
- General knowledge of Access, learning management systems, electronic document management systems
- BS degree required in quality/engineering/science discipline and 5-8+ years of related work experience required
8
Vie-quality Management System Assistant Resume Examples & Samples
- Assist the Northern Europe Cluster Quality Management System Manager in
- Experience and Skills needed: Project management, communication skills and advanced knowledge of MS office are necessary, database knowledge is a plus
- Education needed: Undergraduate degree / Engineering degree / Master / MBA
- Work experience needed: Past internship content may make the difference, but is not mandatory. Work or practice with similar tasks is a merit
- Requested languages: English, both written and spoken is the working language and must be fluent
- Personal abilities or skills
- Team spirit and collaborative mindset
9
Quality Management System Auditor Resume Examples & Samples
- AS9100 lead auditor certification or successful completion of Aerospace Auditor Transition Training (AATT)
- Minimum of 10 years QMS audit experience
- Experience in the Corrective Action process including causal analysis
- Ability to understand and work within complex functional organizations to ensure audits are effectively planned and executed
- Familiar with the use of RCAS
- Develop audit schedules that include appropriate scope and personnel to support
- Execute audits including opening and closing meetings
- Manage Corrective Actions to closure
- Serve as a mentor in the internal audit process
10
Head, Quality Management System Resume Examples & Samples
- Establishment, implementation and maintenance of a Quality Management System in accordance with Novartis and regulatory requirements
- Interacting with internal and external departments to interpret Quality & Compliance information and provide an understanding of how these quality requirements may impact the NIBR organization
- Evaluation of existing Quality System processes across NIBR for the identification of potential gaps to Novartis and regulatory requirements. Work effectively in a matrix environment to prioritize, develop, and implement plans to address these gaps and ensure sustained compliance
- Monitoring the performance of the Quality Management System. This includes formally tracking compliance to the established quality standards, implementation and management of quality review boards, monitoring the effectiveness and establishing a continuous improvement program
- Reviewing quality intelligence applicable to NIBR and recommending appropriate and timely action
- Defining and managing the quality incident and escalation processes across NIBR activities
- Demonstrated experience in a senior Quality Management role
- 10+ years broad experience in a scientific/pharmaceutical/biotech industry. Knowledge of GCP and experience in clinical development considered a plus
- Strong strategic vision and leadership experience including excellent communication, collaboration/consensus building, influencing and negotiation skills
- Demonstrated ability to partake or lead interdisciplinary projects and to effectuate change within a high-performing organisation
- Experience in coordinating/integrating with a wide range of business functions and successfully work globally
- An associate with a courageous, innovative and pragmatic approach, used to developing and leading complex change programs that deliver successful high-quality outcomes for Novartis
- A clear sense of personal accountability, an ability to empower people, and a high degree of mutual respect and integrity are essential factors to succeed
- Strong office IT skills including MS Office suite
- The candidate may be required to travel internationally
11
Quality Management System Specialist Resume Examples & Samples
- Administer the Document Management System in support of Clinical Supply Network SOPs, related forms and other GMP documents as needed
- Manage CSS Network SOP and related forms issuance within the controlled document management system
- Author as applicable CSS QMS SOPs
- Develop or support training documentation for QMS related SOPs
- Coordinate training system updates for new or revised CSS Network SOPs or other GMP documents as required
- Administer computer systems utilized in support of the CSS Quality Management System including change Control
- 2 years’ experience within a GMP Industry is preferred
- Working knowledge of change control, document management and training as it pertains to a GMP environment is preferred
12
Quality Management System Resume Examples & Samples
- QMS specialists from our competitors in the software industry
- Software validation specialists from our customers
- Professional software/IT auditors from the pharmaceutical industry
- Conducting internal and external audits
- Auditing credentials would be a big plus
- Authoring SOPs
- Experience working with software in validated environments
- Experience validating software for use in Pharma
- Knowledge of 21CFR part 11 (USA), Annex 11 (Europe) and/or equivalent Japanese laws
13
Quality Management System Director for a Healthcare Provider Organization Resume Examples & Samples
- Demonstrated quality management and performance improvement experience in healthcare services
- Ability to work collaboratively with all levels of internal and external customers with highly developed written, verbal, and interpersonal communication skills
- Clinical operational experience in healthcare service programs and a demonstrated record of ethical and responsible actions consistent with the values of the business
- Demonstrated leadership qualities and skills, including excellent communication, customer service, relationship development, results orientation, team-building, employee motivation, performance management, critical thinking, problem solving and decision-making
- Pedagogical skills in order to deliver education to a wide audience at various levels and ensure adequate training programs are in place for patients, families, and caregivers
- Current appropriate professional nursing licensure from regulatory agency with legal jurisdiction and masters or higher degree from an accredited school of nursing or doctor of medicine degree
- Additional training and education in quality science
- At least 5 years’ experience in healthcare service management including quality management
- Clinical operational management in renal healthcare services and quality management is preferred
- Multi-site managerial experience a plus
- Additional Languages: Bilingual in Spanish is strongly preferred
14
Quality Management System Auditor Resume Examples & Samples
- Researches directives, policies, processes, procedures, and programs plans
- Analyzes process data, metrics, models, flows, performance, and statistics
- Develops and executes audit plans
- Conducts opening and closing meetings with audit clients and executive management
- Conducts audit interviews and gathers objective evidence to validate compliance to requirements
- Identifies nonconformities and improvement opportunities
- Documents and negotiates audit findings, recommendations, and expectations
- Generates final audit reports with conclusions on compliance
- Communicates audit results to affected parties
- Collaborates with audit clients and action owners to provide Root Cause Analysis (RCA) guidance and ensure effective Corrective Action Plans (CAP) development
- Performs audit follow-up activity to verify effectiveness of corrective actions and implementation of preventive actions
- Performs gap analysis and identifies needed QMS processes
- Ensures QMS implementation and maintenance
- Reports QMS health to key stakeholders, customers, and leadership
- Oversees and supports Corrective Action and Preventive Action (CAPA) boards
- Facilitates Contract Management Office (CMO) Management Council activities
- Coordinates AS9100 3rd party registration and external audits
- Cultivates productive relationships with Defense Contract Management Agency (DCMA) representatives and managing DCMA Corrective Action Requests (CAR)
- Promotes awareness, education, and dissemination of Quality directives, policies, and objectives
- Experience working in a Quality organization
- More than 5 years of experience in Quality Management Systems (QMS)
- Current American Society for Quality (ASQ) Certifications (CQA, CQE, or CQT)
- Experience in any of the following quality systems (HQMS (Harrington Quality Management System), PIMS (Program Information Management System), IQDS (Integrated Quality Data System), EPES (Enterprise Process Evaluation System), QMAS (Quality Management Audit System)
- Experience leading or managing multifunctional teams in Quality or continuous improvement initiatives
- Experience utilizing the following MS Office Applications (Microsoft Excel, Microsoft PowerPoint, Microsoft Project, and Microsoft Word)
15
Quality Management System Leader Resume Examples & Samples
- Bachelor's degree from an accredited university or college or equivalent knowledge and experience
- Significant experience in Quality System Planning and Quality Improvement methods
- Background in engineering, electronics or similar discipline or equivalent knowledge and experience
- Experience in the areas of Engineering, Operations, Manufacturing, or Quality
- Familiarity with a range of Quality tools such as DMAIC, RCA, 8D etc
- Willingness to travel internationally
- Internal Lead Auditor
- Knowledge of standards such as ISO9001:2008/2015
- Strong oral and written communications, interpersonal and leadership skills
16
Quality Management System Resume Examples & Samples
- Bachelor degree required, Industrial Engineering preferred
- 8+ years of experience in process management with 5+ years of experience in designing, implementing and maintaining QMS; Warehouse and 3PL experience preferred
- Six Sigma Black Belt certification preferred, Six Sigma Green Belt certification or equivalent required
- Root cause analysis, auditing, six sigma, statistical chart preparation and coordination
- Certified ISO9001 Lead Auditor or equivalent required
- Experience in leading and applying effective organizational change management techniques
- Experiencing in training others in QMS and continuous improvement principles and tool use including: internal audit, root cause analysis as well as corrective and preventive process improvement
- Experience in implementation and monitoring of program performance, verification and validation methods including experience with statistical and process improvement tools preferred
- Ability to travel on average up to 30%
- Hands-on and results oriented with a strong work ethic and sense of personal responsibility
- Self-starter to lead change and make independent and informed decisions
- Capable of building strong relationships with the functional Business leaders in order to effect change
- Facilitating groups in analysis and program needs implementation
- Strong situational leadership skills to influence all levels of the organization (Senior leaders to operators)
- Intermediate to advanced expertise with Excel, PowerPoint, Outlook, Word, and Visio
17
Quality Management System Manager Resume Examples & Samples
- Runs, manages, coordinates and maintains the management system – including the processes that govern operations and functions – with the aim of meeting the expectations of the stakeholders (Customers, shareholders, partners), as well as the legal and regulatory obligations applicable to both the local aspect and the interfaces with shared services
- Works with the GPOs* (Group Process Owners) and CPOs* (Company/Country Process Owners) to ensure that the processes, procedures and related documents in the management system are consistent and comprehensive
- Takes part in the Management System Steering Committee (MSSC*), the Management System Peer Review (MSPR*) and the Management System Control Board (MSCB*), and makes sure that feedback is provided
- Makes sure that the management system is effectively implemented
- Defines the process application assessment plan. Carries out internal audits and certification procedures. (ISO, EN, etc), monitors related action plans, and organises the experience capitalization process
- Makes sure that the management system is performing correctly (process management by Key Performance Indicators [KPIs]) and prepares Management Reviews with data from assessments, audits, and customer feedback and complaints
- Ensures timely reporting to the management of the entity and to Quality management for risk prevention purposes
- Supports change management, and provides support and guidance to operational teams and process owners (GPOs/CPOs)
- Ensures the availability of norms and standards, and supports their application, as required
- Manages and maintains the entity Chorus 2.0 system
18
Regional Quality Management System Manager Resume Examples & Samples
- Graduate degree in engineering, science, QRC disciplines. Degree in Business management is preferred
- 8-10 years of experience in related field
- Well experience at Quality System Implementation with strong background on QA Knowledge or Operations experience in the pharmaceutical, medical device or consumer products industries
- Must be able to effectively train and mentor employees at all levels of the organization
- Understands current and emerging regulations and the impact to quality and compliance of distribution practices such as FDA, Local FDA, Standards organizations such as ISO 9001, ISO 13485 and Notified bodies such as BSI, TUV etc
- Experience in positions of increasing responsibility, with broadly based quality management experience
- Experience with the global demands of the role specifically: healthcare regulatory requirements.Quality (Generalist)
19
Quality Management System Specialist Resume Examples & Samples
- Responsible for compliance with the ISO 9001 standard for Canada
- Develop and maintain the QMS and documentation system to ensure compliance with approved process and procedures
- Ensure that the document control procedure is adopted to approve, review and update all changes to critical documents within the scope of the QMS
- Ensure quality records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records
- Organize and lead annual Management Reviews of the Quality System to ensure and monitor its suitability, adequacy and effectiveness
- Co-ordinate continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed. Work with process owners to ensure timely CAPA investigation and closure
- Define and implement a QMS training program. Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide update training as necessary
- Analyze data on the effectiveness of the QMS and evaluate where continual improvements of the QMS can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources
- Support departmental process owners to identify, implement and document improvement opportunities
- Assist in creation of quality objectives for RAQA and non-RAQA departments
- Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with internal and external requirements/standards
- Report to top management on the performance of the QMS and any need for improvement
- Partner with RAQA to establish best practice and standardize processes where possible
- When requested, provide support to other members of RAQA team to facilitate the meeting of their requirements / targets
- Working knowledge of ISO9001 Requirements
- 3-5 years with QMS responsibilities
- Strong computer skills (Excel, Word, Power Point, SharePoint), Trackwise and ComplianceWire will be considered an asset
- High standard of integrity and ability to meet deadlines
- Highly organized and able to prioritize tasks
- Strong oral and written communication skills with both internal and external contacts
- Ability to make and support decisions with regards to quality issues
- University Degree required
- At least two years’ experience in a regulatory affairs and quality assurance environment an asset
- Internal applicants with an equivalent combination of education, experience and performance over time at Stryker will be considered
20
Quality Management System Business Analyst Resume Examples & Samples
- Work with other IT areas on cross-departmental/inter-company projects and new application requirements
- Knows and executes best practices for business analysis processes and functions (from an industry and strategic standpoint), including requirements elicitation methods
- Defines requirements in accordance with SDP/SDLC, management and project/product scope. Ensures problem statements and objectives are clearly defined. Ensures requirements are aligned to project scope, objectives and strategies
- Leads elicitation sessions using variety of requirements gathering methods such as interviews, documentation analysis, surveys, and site visits. Develops a business model with executives, managers, developers and subject matter experts to ensure alignment with requirements
- Facilitates the team through the analysis of, and makes recommendations towards, complex business decisions
- Mediates across different IT teams utilizing knowledge of IT and roles and responsibilities within the organization
- Focuses on process analysis and re-engineering, with an understanding of technical problems and solutions as they relate to the current and future business environment
- Demonstrates excellent listening, communication, and facilitation skills
- The candidate must have the ability to write detail user requirements by leading collaborative requirement sessions with end users and IT resources for requirements sign-off and document use cases to ensure user work flows are understood
- The candidate must have experience with project methodologies such as Agile and Water Fall
- Candidate must be familiar with HP ALM and have great written and verbal communication skills
- The candidate will own requirements through design and build phases by working with IT resources to ensure user needs are met during those phases and project scope is managed, and the candidate must be able to complete traceability between approved requirements and test cases by working with test team
- The Candidate must have knowledge with test phase, have experience with managing test defects and participate in project Go-Live
- Candidate must have the ability to report findings/status to project team and stakeholders throughout the life of a project
- The candidate must have a track record for contributing to small to large complex projects, work in group settings and have the ability to work autonomously
- Bachelor degree in Computer Science, Management Information Systems, Engineering or related area
- Experience in the Health Care/Life sciences and/or FDA Compliance disciplines
- Detailed knowledge of application development process, agile methodologies, and Quality Management Systems
- Our ideal candidate will possess 5+ years of experience in the healthcare industry focused on Quality processes
- The candidate should have experience in managing the requirements elicitation process and ensuring solution delivery meets business requirements while leveraging existing solution capabilities wherever possible
- Additionally, the individual should have strong interpersonal skills and is adept at building relationships within the business areas they are supporting
- Excellent communication skills, customer service, and client management experience are essential
21
Quality Management System Manager Resume Examples & Samples
- Leads, organizes, assigns and oversees audits of parts, materials, components, maintenance and other corporate procedures for compliance to stated requirements. Directs the activities of Quality Auditor(s) who are engaged in internal and external audits both domestically and internationally
- Interfaces with department leadership to ensure appropriate procedures are used in day to day business
- Defines, plans, monitors, and reports on quality audits, supply base, corrective actions and procedural enhancements which address Thales’s business requirements as well as supporting the business functionality
- Manages the overall relationship between compliance and other quality related activities of affected business units or departments. Guides the allocation of resources as necessary, along with publishing appropriate regulatory documentation to business functions
- Manages a portfolio of multiple projects potentially across multiple departments and recommends product solutions as required
- Oversees the management of quality documents; the preparation of document packages for audits, supplier activity and corrective actions
- Interfaces with the Federal Aviation Administration (FAA) on matters of compliance to regulatory requirements including requests for additional capabilities
- Manages the departmental financial budget
- Provides guidance and regularly assesses requirements to ensure that budget funding, resources and product specifications are aligned to business expectations in accordance with required policies, standards and procedures
- Other duties as assigned by Team leader
- Five (5) years managerial experience in an FAA FAR-145 Repair Station and FAR-21 manufacturing quality assembly and test
- Three (3) years’ experience with compliance level interaction with the FAA in both the FSDO and MIDO offices
- No history of violations with any Federal Aviation Regulation regarding manufacturing or repair
- Valid, unrestricted Passport with the ability to travel in and out of the United States or ability to obtain one
- Regular attendance and punctuality is required
- Must have a positive attitude
- Organizational fit for the Thales culture, that is, exhibit the Thales values of Compliance, Respect, Innovation, Responsibility, Teamwork
- Well groomed and maintain a professional appearance
- Possess and maintain a valid Driver License and a record that meets our parent company’s insurance standards
- Must be willing to travel on a regular basis both domestically and internationally (30%)
- Knowledge of Microsoft Office Suite, including Outlook, Project, Excel and Word
- Broad practical experience with a variety of technologies including precision measuring and test equipment
- In-depth knowledge of FAA airworthiness conformity concepts, strategies and methodologies
- Thorough knowledge of FAR Part 21, Part 145 and Part 121
- Knowledge of management concepts, practices and techniques
- Ability to promote a team environment
- Strong negotiation, facilitation and consensus building skills
- Strong verbal and written communications skills; presentation skills
- Accountable and results-driven
- Knowledge of budget processes
- Strong interpersonal, leadership and managerial skills including the ability to motivate others
- Ability to work well with others and complete tasks with minimal supervision and manage risks
- Ability to tailor communication style to different audiences, and to exercise good judgment in frequency and nature of communications to different parties (senior management, team members etc.)
- Ability to work in a high-pressure environment
- Excellent problem solving and structured thinking skills
- Flexibility, agility and change management skill
- Makes sure that the management system is effectively implemented. Defines the process application assessment plan. Carries out internal audits and certification procedures (ISO 9001, AS 9100), monitors related action plans, and organizes the experience capitalization process
- Ensures the availability of norms and standards, and supports their application where necessary
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EDN Quality Management System Associate Resume Examples & Samples
- The Quality Management Associate is responsible for the review and improvement of the quality management system and will coordinate the QS activities
- You coordinate the activities of inspections readiness and ISO certification if required
- You review and improve processes of the QMS, ensure that KPIs are in place
- You collaborate for the definition of Quality objectives and for the development of a quality mindset
- You collaborate and provide input for Quality Improvement Program meetings and Quality Management Reviews
- You participate in the development of new project implementations with a specific QA & Regulatory focus
- You take the role of training coordinator in order review training curricula, will create training materials and will develop / train the EDN personnel in order to ensure that operational personnel has an appropriate understanding of the Good Manufacturing Practices and Good Distribution Practices
- You take the role of Business administrator for the document Management system
- You conduct and assist internal audits of EDN departments. The goal of these self-inspections is to perform an in-depth review of the operation in view of the applicable cGMP and GDP regulations
- You support CLS-EMEA QMS owner on the creation, the update and audit of shared processes
- You work in line with Credo values, Janssen Supply Chain and J&J Supply Chain requirements
- You assist in the preparations of external and internal inspections related to overall quality and compliance
- You work in line with the Safety, Health and Environmental principles
- Bachelor/Master
- Good knowledge of (c)GMP and GDP standards
- Good knowledge of Pharmaceutical regulations
- Good knowledge of Medical Devices regulation
- Good knowledgeISO Standards
- Quality experience in pharmaceutical/medical device environment
- Knowledge of main IT tools, commonly used in the pharmaceutical sector (e.g. TrackWise®,..., SAP)
- Experience as quality external and internal auditor
- Presentation & training skills
- Incident and complaint Management System (TrackWise®)
- Learning Management System (ComplianceWire)
- Electronic Document Management System (Tru- Vault)
- Microsoft Office application®
- English: full Professional proficiency
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Quality Management System Specialist Resume Examples & Samples
- Manage external documents and web-based subscription services including standards, specifications and technical papers required by the business. Status and maintain current specifications and post change announcements as required. Procure and fulfill request for various industry standards and specifications as new documents are required
- Upload quality system data deliveries required by contract to customer portals, assuring on time delivery and contract compliance
- Manages SpaceX stamp control process and system including procurement, inventory management, distribution, traceability and disposition of stamps across multiple organizations and sites
- Participate in corrective and preventive action processes supporting action teams with guidance and helping to drive overall process timeliness
- Conduct routine audits to assure system and process compliance in accordance with prescribed requirements
- Must have at least 5 years of experience in quality or technical engineering with focus in quality management systems or operations
- Direct experience implementing and improving automotive, medical or aerospace quality management policies with a working knowledge of the AS/ISO family of standards is strongly preferred
- Strong working knowledge of AS9100 quality standards
- Strong technical writing skills, the ability to communicate effectively with management, technical teams and all organizations in the business, and strong problem solving skills
- Knowledge of control of nonconforming hardware, failure/root cause analysis, and corrective and preventive action processes
- Demonstrated competence in working with diverse personnel to resolve issues with short deadlines
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Quality Management System Design Controls Manager Resume Examples & Samples
- Minimum of five (5) years of combined experience in product development and/or quality engineering
- Experience in product development
- Experience leading or working with quality management system processes and methodologies
- Experience in performing process redesign
- Experience of successfully leading teams through change (change management)
- Ability to work within team structure to influence and support quality improvement
- Experience of working in Health care and knowledge of Health Care Regulations
- Experience of influencing Senior Leaders and global teams
- Ability to work in a large, highly matrixed organization
- Strong organization skills and ability to juggle multiple requests
- Independent, self-motivated, and achievement driven
- Flexible attitude and ability to meet diverse needs
- Customer service oriented and desire for continuous improvement
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HR GBS Quality Management System Specialist Resume Examples & Samples
- Post Graduate Diploma Human Resource Management/Equivalent Post Graduate in HR – will be considered a strong plus
- Previous experience in HR Shared Service Center environment and/or QMS will be considered a strong plus
- Ability to learn and adapt to new changes in the process
- Demonstrated ability to successfully work within a team and believe in the concept of ‘team work’
- Proficient Knowledge of MS Office (Word, PowerPoint, Excel – very good level)
- Sense of urgency and client service oriented
- Excellent verbal and written skills in English and Romanian are mandatory
- Interpersonal skills; Initiative; Flexibility
- Experience in usage & reporting of systems
- Reporting in the prescribed formats
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Quality Management System Expert Resume Examples & Samples
- Drive QMS gap closure by implementation of globally defined policies/rules and updating of local business processes and procedures
- Alignment with other sites (led by global QMS) on process setup and/or core quality business rules for high level business processes
- Drive/Support the local certification process
- Preparation/organization/moderation of certification and customer audits
- Support execution of internal audits according actual audit plan
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IMS Business Analyst Intern Quality Management System Resume Examples & Samples
- Pursuing a degree in Informatics, Information Systems, or Business Administration
- Areas of study include Database Concepts, Enterprise Resource Planning and/or Quality Management Systems
- Highly proficient in Excel
- Strong working knowledge of Microsoft Office Applications
- Interest in growing knowledge in business processes and project management
- Required skills in organization, communication and customer service
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Internal Quality Management System Auditor Resume Examples & Samples
- Bachelor’s degree or equivalent in Business, Operations Management, System Analysis/Computer Science or related field
- Internal Auditor Qualifications or Lead Assessor training
- 1+ years conducting internal quality audits and driving CLCA
- Experience with Microsoft Office applications such as Excel and Visio
- Experience of Kaizen principles SCRUM Methodology (or equivalent) and Lean/Six Sigma principles experience
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MTB Quality Management System Manager Resume Examples & Samples
- Manage Quality Management Systems (QMS)
- Increase efficiency and effectiveness of the QMS and its processes
- Ensure compliance to standards
- Contribute to planning and review of QMS
- Communicate with Global Internal and External Customers
- Consult with department leadership on QMS Standards and initiatives
- Promote awareness of QMS direction and status through global updates
- Contribute to the promotion and awareness of customer requirements
- Provide Technical Leadership and Support
- Maintain knowledge of QMS standards, methods, and tools
- Provide support to internal functions on the application, maintenance, and improvement of quality systems and department-specific processes
- Maintain knowledge of Project Management and tools
- Deliver presentations and training courses including measurement, analysis, improvement, and control
- Manage and Develop the Team
- Coach and provide career development
- Identify strengths and create specific development plans
- Establish goals and conduct performance appraisals
- Provide recognition and drive accountability
- Provide training
- Interact daily on task with team members
- 10 years experience in each of the following
- Knowledgeable in Business Process management and Quality Management tools
- Knowledgeable in ISO 9001 and ISO/TS 16949 QMS Requirements
- High degree of self initiative and ability to think and act independently
- Good multi-tasking and problem solving skills
- Possess ability to work under tight timeframes and prioritize competing activities
- Excellent organizational and management skills and outstanding interpersonal and teamwork skills
- Strong verbal and written communication skills and outstanding interpersonal and teamwork skills
- Proven ability to collaborate well with cross-functional teams to understand needs and translate them into actionable plans, deliverables, and resource requirements
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Quality Management System Supervisor Resume Examples & Samples
- Organize and host customer audits
- Coorindate and minute site management review meetings
- Ensure that product quality is maintained throughout the manufacturing process by quality audit / assessment and implementation of recommended quality improvements
- Investigate Quality Notifications (Customer complaints)
- Load product formulations and SOPs onto SAP as and when required
- Act as training Co-ordinator for MasterControl – Electronic Document Management system
- Manage the change control system
- Provide Quality input to product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs
- Provide QA oversight of CSV activities pertaining to e-QMS applications
- Review and approve validation documentation
- Effectively lead a team of QA members in the maintenance of existing QMS and implementation of system improvements
- Ensure the internal audit programme is maintained appropriately
- Effectively lead a team of at least 3 QA members in achieving department and individual team members’ objectives
- Bachelor’s degree preferred in science discipline (chemistry, biology, etc) or related field
- Medical device (ISO 13485, 21 CFR 820), or GMP (21 CFR 820, 210, 211, Eudralex) background
- Experience in auditing practices and principles; formal internal and external auditor training required
- Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) and Six Sigma / PPI
- Strong working knowledge of various computer software, such as SAP, MasterControl, as well as Microsoft Word, Excel and PowerPoint
- Experience with lean manufacturing practices
- Develop others as well as self
- Proven experience in supervising a small team
- Significant experience in administering quality systems such as change control, CAPA, training, etc
- In-depth experience in the development and implementation of electronic Quality Management Systems such as CAPA, change control, training, documentation, etc
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Quality Management System Auditor Resume Examples & Samples
- QS9000 or VDA6.1 or ISOTS16949 quality management experience in production field
- 5 years working experience in Quality or related field, preferable in automotive field, having internal auditor experience
- Must have experience with 5 whys and the 8D process
- Would like to have ISO/TS 16949 Certification but not mandatory
- Should have at minimum, average computer skills being familiar with Microsoft Office(PowerPoint, Excel, Etc)
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Quality Management System Program Manager Resume Examples & Samples
- 5+ years healthcare experience
- Expert knowledge and work experience in quality management, patient safety, systems thinking, change management
- Expert knowledge of hospital operations, systems and processes
- Demonstrated ability to create and implement process improvements to attain desired outcomes
- Demonstrated expertise and success in team facilitation skills
- Innovative and willing to constructively challenge established ways and methods
- Knowledge and experience in the interpretation of regulatory standards
- Ability to develop and maintain effective working relationships with leaders, medical staff, core leaders and front line caregivers
- Strong communication, interpersonal, training and presentation skills
- Proven success in project management
- Understands organizational dynamics, demonstrates ability to build partnerships with medical staff and lead others toward goal achievement
- Ability to adjust work schedule to meet needs
- Travel approximately <20%
- Masters’ degree in nursing, business, applied behavioral science, hospital administration or related subject preferred
- Electronic Health Record experience
- Proficient in Access preferred
- ISO 9001 experience preferred
- Six Sigma and/or Lean preferred
- Expertise in statistical process control techniques and tools
- Demonstrated ability in implementing large-scale projects
- Current knowledge of CMS CoP requirements
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Quality Management System Manager Resume Examples & Samples
- Lead the adoption of ISO 13485:2016 for the division, including Quality Planning and implementation
- Lead the Quality Management System harmonization between the division’s sites
- Provide Quality System expertise to the organization and ensure compliance to ISO 13485, QSR and other applicable Quality System Regulations by supporting interpretation of regulations, performing gap analysis and lead activities to implement improvements
- Investigate, and resolve Quality System non-conformities (defined during internal and/or external audits)
- Participate in or lead the completion and maintenance of risk analysis related to quality systems
- Prepare for external audits and support or participate during external audits
- Take ownership for specific business processes as assigned
- Train personnel on Quality Management System related topics
- Have worked with quality management systems in an IVD/Medical device environment (e.g. QSR, EU medical directive, ISO 13485, ISO14971) and have significant experience of analyzing and interpreting regulations, directives and standards
- Have strong leadership and interpersonal skills, and drive cross-functional collaboration capabilities
- Be someone who works analytically, enjoys problem solving and who is able to drive the work forwards and complete it in the allocated time
- Cross-functional collaboration is key to success in this role
- Be organised, target driven and good at identifying process objectives and process mapping
- Speak English and Swedish fluently and have strong communication skills, including cross-functional communication
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Quality Management System Supervisor Resume Examples & Samples
- Manage the data for MasterControl system
- Experience in supervising or leading small teams to a successful outcome is essential
- Proven experience in QMS
- Willingness to undertake on the job training in all areas of the supply chain
- Current clean driving record
- May be required to perform other related duties as required and / or assigned
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Quality Management System Program Manager Resume Examples & Samples
- Bachelors Degree in Nursing, Lab Technologist, Physical Therapist, Pharmacist, RHIA or other clinical healthcare education required
- Five (5) or more years healthcare experience
- CHPQ Certification required
- Valid Washington State driver’s license is required
- Proficient with MS Office Suite programs including Word, Excel, PowerPoint,
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Quality Management System & Quality Engineer Resume Examples & Samples
- Support all functions for the management of Practical Problem Solving (PPS). Correct and take preventive actions, as well as the consolidation and reporting of it. This will be partly done through Quality Reviews and Quality Councils
- Support the maintenance of ISO 9001, IRIS and other relevant certification for all sites in the area of responsibility (BU/region/division) including the local application of the BTGroup Quality Policy
- Conducts internal audits in the site/BU/region/division
- Report of process performance and process maturity assessment, including KPI reports (CARs, time to close open items, etc) and management summary
- Support the evolution, improvement and deployment of BT Integrated Business Processes for the area of responsibility (site/BU/region/division)
- Verify processes of all functions with only local focus
- Ensure consistency of local process development with division/Group wide process development, aligned with the divisional BTIP coordinator
- Facilitate the integration of local process documentation into the global system
- Review process documentation of other functions on behalf of Quality
- Contribute to the development of process documentation owned by the Quality Function
- Supervise local process deployment and awareness by all functions
- You hold a Bachelor’s Degree in Engineering
- You possess a minimum of ten (10) years of post graduate experience
- You have a minimum of five (5) years of leadership experience
- You have experience in commercial, technical writing, sales and marketing
- You possess experience in IRIS, ISO 9001, BT Value Chain and other relevant standards, such as OHSAS 18001, ISO 14001, EMAS
- You have Quality or HSE management experience and (internal) auditor experience
- You possess knowledge in Certification process of relevant standards
- You have Knowledge of Bombardier Transportation Integrated Processes (BTIP), Bombardier (BOS) Operations System, Bombardier Engineering System (BES) and other BT assessment
- You possess knowledge of BT processes
- Your English and French communication skills are excellent, both written and spoken (Spanish and Portuguese would be considerer as an asset)
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Continuous Improvement & Quality Management System Manager Resume Examples & Samples
- Train the local AES Experts (and any other relevant stakeholders such as executives or management teams) on AES methodology, tools & deployment roadmap
- Coach AES Experts in deploying and monitoring AES in their area of responsibility
- Drive with AES experts all relevant activities to install AES mindsets and behaviours within the organization
- Main activities include Case for change, Key stakeholder analysis& monitoring, Stakeholder positioning & Management, Communication Plan, Training Plan etc
- Support management teams in increasing their efficiency and team coherence
- Systematically apply coaching techniques and tools to support managers and team members in improving their performance
- Share lessons learnt, best practices and risks within region/functions and with other AES region leaders
- Build and drive the AES expert network in the region/function
- Lead the development & implementation of the continuous improvement system on site
- Identify and leverage best practices in Continuous Improvement throughout the organization and ensure their implementation
- Participate in assessments as leading expert and give support
- Support business process improvement and process design/re-engineering activities
- Act as the Change Agent in the transformation process introducing the continuous improvement culture
- Coordinate LEAN team activities to ensure the full and successful implementation
- Train and coach other employees in advanced continuous improvement & lean production activities and problem solving
- Managing and support to all functions for the management of corrective and preventive actions, as well as the consolidation and reporting of it
- Maintain ISO 9001, IRIS, CMMi and other relevant certification for all sites in the area of responsibility (BU/region/division) including the local application of the BT Group Quality Policy
- Plan, monitor and lead internal audits in the site/BU/region/division
- Lead monitoring and reporting of process performance and process maturity assessment, including KPI reports (CARs, time to close open items, etc) and management summary
- Coach AES Experts and help them to coach leaders who are change sponsors and agents to support the execution of change plans
- Coach the senior management of the site in their continuous improvement transformation both from a behavior and tool aspect
- Coach and develop the AES, CI, & IMS team, to plan their activities on a week by week basis and to assist them in problem solving and change management techniques
- Provide expert advice to improvement initiatives/projects across departments. Lead and co-facilitate complex or cross-functional improvement projects and workshops
- Manage and support the evolution, improvement and deployment of BT Integrated Business Processes for the area of responsibility (site/BU/region/division)
- Coordinate work of respective Process Operators/Business Process Owners/Process Owners in your organization
- Verify processes of all functions in your organization
- Ensure consistency of process development with Business Process Owners/Process Owners wide process development
- Facilitate integration of process documentation into the global system
- Assure that business processes are consistent with (as required) IRIS, ISO 9001, CENELEC, ISO 14001, OHSAS 18001 and other relevant standards
- Supervise process deployment and awareness by all functions
- You hold a Bachelor Degree or equivalent, preferably a master degree in Engineering, Quality, Operations, Business & Administration or equivalent
- Your Coaching certification is a plus
- You possess ten (10) years of post-graduate experience and from three (3) to five (5) years in a relevant role
- You have experience in architecting, documenting and managing process documents
- You have passion for leading change and for continuous improvement
- You possess experience in managing projects in a multi-functional / multi-cultural environment
- You have experience of training, coaching and supervision
- You have proven ability to lead change in collaboration with senior management, involving several functions/site/organization
- You own profound knowledge of continuous improvement, change management and Lean principles (Problem solving, value Stream mapping, 6 Sigma, Kaizen moderation, KPIs and all other relevant CI tools) and ability to apply and to coach others
- You possess Quality or HSE management experience and (internal & external) auditor experience
- You have proven track of influencing skills from worker level till executive level
- You own proven ability to adapt to ambiguity and changing situations
- Your English and French communications skills are excellent both written and spoken
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Quality Management System Experts Resume Examples & Samples
- Bachelor/Master degree with a couple of years relevant experience in Quality functions
- Background in a Regulated Industry (IVD, Medical Devices, Pharma, Aerospace, Automotive) is required
- Experience in an R&D environment is a strong pre
- Demonstrated experience in setting up and maintaining compliant Quality Management Systems is required
- Demonstrated experience with product safety risk management is a preference
- Strong communication and influencing skills
- Travel up to 10% globally
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Quality Management System Program Manager Resume Examples & Samples
- Bachelors Degree in Nursing, Lab Technologist, Physical Therapist, Pharmacist, RHIA or other clinical healthcare education
- CHPQ Certification preferred
- Ability to adjust work schedule to meet needs; travel approximately <20%
- Proficient with MS Office Suite programs including Word, Excel, PowerPoint
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Quality Management System Senior Specialist Resume Examples & Samples
- Establishment, Implementation and Sustainability of Integrated Management Systems in the company
- Knowledge in Quality Documents and Environmental subjects, following the developments
- Work in Quality, Customer, Product, Documentation and all kinds of system audits (ISO 9001, ISO14001, ISO27001, TAPA, HACCP, OHSAS...)
- Performing Efficiency and Appropriateness Audits in Company and in Business Partners in regards of Management Systems; Machinery, Equipment etc. Measurement Analysis; Environment Legislation
- Continuous Improvement, Benchmark and Best Case studies
- Preparation, revision and communication of documentations
- Bachelor's Degree (Preferably in Environmental Engineering)
- Minimum 2 years of expertise in Quality Management Systems
- Prefarrably experienced in Quality Audits (Internal & External)
- Experienced in establishing and integrating Quality Management Systems
- Very good level of communication skills
- Presentable
- Very good command of presentation skills
- Very good command of MS Office programs
- Very good level of English
