Director, Quality Assurance Resume Samples

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K Sipes

Kassandra

Sipes

939 Franco Brook

Detroit

+1 (555) 750 0108

939 Franco Brook

Detroit

Phone

p +1 (555) 750 0108

Experience Experience

New York, NY

Director Quality Assurance

New York, NY

Anderson Inc

New York, NY

Director Quality Assurance

Provide Leadership to maintain a business wide culture of quality and work collaboratively to set quality strategic direction
Manages processing and completeness of medical staff and allied health professional applications for appointment, reappointment, or privileges in accordance with Medical Staff Bylaws, Rules, and Regulations, and policies and procedures
Implements and manages quality activities throughout the facility including peer review, quality initiatives and other PI activities
Work with the Clinical Laboratory Director and US QA Director to review all Quality documents for regulatory compliance
Management of departmental budget
Demonstrate strong proficiency in the application of the Corrective and Preventive Action system, to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources
Provide QA oversight for materials management program and sample inspection process for all incoming materials

Boston, MA

Director, Quality Assurance

Boston, MA

Johnston-Veum

Boston, MA

Director, Quality Assurance

Assist in establishment of quality assurance and control policy by providing consultation and recommendations to regional and Global QA Management
Provides continuous support, training, mentoring, and development to ensure Cincinnati Quality performs at a maximum performance level
Maintain, communicate, and execute an effective performance management program
Develop and execute test governance framework and processes
Establish Quality Baselines & Metrics - Target date management, Estimate creation and Performance measurement
Constantly evaluate the test automation strategy and approach to identify areas of improvement (i.e. test automation frameworks, tools, etc.)
Conduct trend analysis of audit results and provide QA management with initial root cause analysis

present

Los Angeles, CA

Senior Director, Quality Assurance

Los Angeles, CA

Sporer LLC

present

Los Angeles, CA

Senior Director, Quality Assurance

present

Develops and maintains Master Control (EQMS) system for procedures, work instructions and forms
Formulates and administers policies and standard operating procedures (SOPs) relating to the quality assurance function and the quality management system
Uses incident and Corrective and Preventive Action (“CAPA”) activities and processes to drive quality improvements and respond to process and service issues
Guides the development of all quality assurance activities and quality management system processes
Maintains quality through internal and external inspection of raw materials, finished items purchased and production operations and processes
Responsible for planning and directing quality control programs involving inspection methods, devices and controls
Defines, develops and implements short-term and long-term strategies, goals, objectives and tactics relating to the regulatory and quality assurance function and the quality management system

Education Education

Bachelor’s Degree in Business Administration

Indiana University

Bachelor’s Degree in Business Administration

Skills Skills

Strong attention to detail and proven ability to meet deadlines
Excellent oral and written communication skills, including the ability to organize and present information in a clear and concise way to executive leaders
Knowledge of Security and compliance policies and procedures and their applicability to areas of responsibility and vendor management
Proficient and strong understanding of project development life cycle and software development life cycle
Excellent verbal and written communication skills, including the ability to bridge the gap between technology and business
Excellent Quality Assurance/Testing skills
Strong verbal and written communication skills, with an ability to express complex technical concepts in business terms
Advanced knowledge of the organization, industry, and quality assurance best practices
Understand, interpret and act on financial information that contributes to business profitability
Familiar with test equipment basics and basic statistical analysis

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Director, Quality Assurance Resume Examples & Samples

Lead the QA organization across the MHE Israel development teams. Team members will include employees and contractors
Develop, define and maintain all quality assurance (QA) processes surrounding all applications and infrastructure to ensure quality standards are met for all MHE product engineering applications
Develop and maintain service level adherence criteria for all MHE digital products
Maintain high quality standards for digital products generating multi-million dollars in stand alone digital revenue and supporting multi-million dollars Higher Education business
Maintain MHE digital products brand equity by ensuring high quality software product development
Maintain QA budget as allocated from the overall products/team budgets
Lead team of 7-8 including consultants, adding additional resources only when necessary
Reduce costs and risk of customer support and product adoption through the quality assurance process
Bachelor's Degree in Computer Science or related experience
Extensive software quality assurance experience, to include significant experience in a lead role or management position
Must have a strong background and experience within software development (as a developer)
Strong analytical skills and experience with implementation and administration of Software Quality Assurance metrics, such as defect profiles and performance to entry/exit criteria
Excellent problem solving, interpersonal communication and project management skills a must
Strong leadership skills that inspire team confidence and respect while motivating team members in a creative and effective manner
Strong understanding of different software development life cycles (waterfall, iterative) and contemporary software quality assurance processes and automated tools
Excellent co-ordination/communication skills are required. Project involves working with different software development groups outside our team
Must have demonstrated experienced in the following testing tools: Quality Center or upgrades, Quick Test Professional or upgrades, Selenium, JIRA
Must have demonstrated experience in the following technologies: Mobile technologies, C, SQL

Director Quality Assurance Resume Examples & Samples

Bachelor’s degree required from an accredited university in scientific, pharmacy or related field
Minimum of 7 years of experience in Quality Assurance or Regulatory Compliance, with at least 5 years of cGMP auditing experience, and at least 3 years project or resource management experience, or equivalent combination of education and experience
Prior experience operating in and managing change control programs in the biotech or pharmaceutical industry
Working knowledge of regulatory compliance and QA issues within a pharmaceutical organization
Experience in a global environment from a regulatory/GXP perspective

Director, Quality Assurance Resume Examples & Samples

Accountable for product quality for Timberland by managing Quality and Product Safety teams, processes, reporting and ensuring continuous improvement
Ensure all Timberland Quality Standards are accurate, complete, and up to date. Create new standards as required to manage the business and indirectly manage the incoming audit process and auditors at US based DC
Oversee and provide guidance to VF Asia in the Timberland vendor qualification process. Ensure that the process is representative of Timberland’s Quality and Product Safety requirements
Establish and direct, in conjunction with RD&D, a Timberland new style design conformance process. Ensure that new styles conform to Timberland’s Quality requirements. Drive root cause and corrective action for non-conforming styles. Identify changes to standards and processes that result in a stronger process
Direct and provide guidance to VF Asia in the Manufactured Product Conformance Process. Identify problem vendors and ensure that Quality performance and Product Safety corrective actions are established
Establish and direct all aspects of a Timberland Product Field Conformance process including quality alerts, returns disposition and processing, and recalls. Ensure that we are capturing all field-based product quality indicators and systematically using them to evaluate and design future products
Responsible for reporting and managing Timberland Quality and Product Safety metrics. Develop new metrics as needed to manage the business
Develop strategies to manage all critical gaps in the Timberland Quality and Product Safety architecture
Oversee and ensure execution of Timberland's RSL and product safety policies in conjunction with VF Asia, update and amend as needed
Develop strategies to ensure compliance with new regulations and requirements in order to mitigate product risk

Director Quality Assurance Resume Examples & Samples

Possesses a university degree and/or 12+ years relevant work experience
Possesses advanced knowledge and 10+ years of experience in project and program management, including managing large-scale projects or programs of significant complexity and value (> $10MM) with high risk
Industry-specific knowledge and experience is an asset
Holding a valid PMP designation from the Project Management Institute (PMI) or other valid program management certification (e.g. Prince 2) is an asset
Excellent relationship management and consulting skills which results in proven ability to quickly earn the trust of sponsors and key stakeholders, mobilize and motivate teams; set direction and approach, resolve conflict, deliver tough messages with grace, execute with limited information and ambiguity
Expert change leadership and change management skills
Applies an appropriate depth of perception, discernment and judgment to effectively direct a program in a changing and evolving environment
Excellent stakeholder management and influencing skills, capable of balancing multiple perspectives, effective at all levels up to senior executive
Sound business and technical acumen, with demonstrated agility in learning and ability to quickly become comfortable with unfamiliar businesses areas or of technologies. Ability to connect programs/projects to broader organizational goals and grasp the key performance drivers of business partners
Expert presentation, written and verbal communication skills which bring clarity and precision at senior executive levels
Excellent problem-solving and critical-thinking skills to recognize and comprehend complex issues, policies, regulatory requirements and industry information affecting the business environment. Seeks opportunities to improve business outcomes
Exemplary core program and project management skills including multiple aspects of the PMBOK (i.e. Project Management Institute's PM Body Of Knowledge)
Solid knowledge and expertise in the use of program management methodologies (e.g. Prince 2) and tools (e.g. Clarity, MS Project, SharePoint repositories, Systems Development Life Cycle (SDLC) if applicable)

Director, Quality Assurance Engineering Resume Examples & Samples

Provide QA leadership for engineers engaged in testing of deliverables, including building a high-performing QA organization and adopting/applying the best-in-breed QA tools, techniques and practices
Championing customers experience across engineering community. Test to deliver awesome customer experience
Lead automation of all types of testing and harnessing it a process of continuous testing and functional/non-functional coverage
Attract and retain solid QA talent and manage resourcing across various projects
Partner with development operations on release management
Leverage existing centers of excellence where necessary
Deliver high quality customer-driven software products to market that simplify and solve for current customer needs while building for the future
Responsible for initiating and driving the adoption of technology, product and process improvements throughout the software delivery lifecycle
Provide technology and thought leadership in quality assurance
Build a high performing, results-oriented organization and manage allocation of resources to various projects
Drive and own the Quality roadmap for your organization
Drive initiatives to improve testing at all levels & deliver automation to ensure robustness and protect our customer
Create a shared vision of product quality and maintain strong cross-functional relationships / alignment within & across the business units
Operates from a mindset of end-to-end ownership working closely with Technology teams and Production Operations staff
Partner with Development teams to prepare for timely and smooth acceptance of deliverables into production environment
Has a customer-driven mindset and insatiable appetite for engineering excellence
Overall experience of 12+ years with several years in Software Operations Management related
Must have lead QA organizations in product-based environments
BS/MS in Computer Science/Engineering or equivalent
Persistence to pursue and implement automated QA solutions in a continuous integration environment
Strong understanding QA automation tools and a passion to learn and apply new solutions to business needs
Demonstrated experience leading positive change, empowering people, cultivating product technology visions and innovative solutions, and fostering effective engineering teams
Adept at articulating the quality vision and drive change with strong business acumen
Experience working in Agile environments
Strong interpersonal skills to coordinate with other organizations across the business while managing customer expectations
Has a proven track record for developing people, teams, and strong partnerships with other functional and remote teams
Ability to coach and mentor software operations/SCM/Support engineers and operations resources for personal and professional growth

Director Quality Assurance Tools & Methodology Resume Examples & Samples

Interlocks with the interfacing organizations at the management level in order to promote the procedures and processes that the QA Tools and Methodology will be employing to order to gain agreement and acceptance of these processes
Brings extensive quality and test management experience and thought leadership in the development and on-going management of the Quality Assurance, whether it be waterfall, iterative or agile methodology and encompassing a number of implementation strategies
Directs a team of quality assurance professionals to ensure quality practices are built into the overall delivery lifecycle
Actively provides metrics to the management team on progress throughout the lifecycle, as well as issues/risks and mitigation of those risks
Implement and own a holistic approach to test planning through a standardized process and methodology using industry leading quality assurance practices
Innovate, create alignment and delveop a shared understanding of QA methodology/ processes
Provide thought leadeship, educate and propogate industry findings, best practices and resources
Champion the introduction of Continuous Process Improvement initiatives across the SDLC to improve quality
Build and direct a team that develops, applies and maintains quality standards and written policies and procedures that govern the day-to-day tasks of the QA function with adherence to both internal and external standards
Drive improved automation capabilities, including building automation into the test plans at the early phases, Increasing the breadth of automation (eg. report/statement validation, large data compares)
Research, recommend, introduce new tools and techniques to improve efficiency and effectiveness across the SDLC
Collaborate with developers, service and support management, release management and test execution teams to align development and QA approaches regarding
Define and implement Test Data Management capabilities, and reduce data conditioning/preparation activities
Maintain ongoing status reporting and pro-actively address potential delays
Establish strategic partnerships and develop positive working relationships with internal and external stakeholders to drive the end-to-end Quality functions in a collaborative manner
Provide guidance, direction and escalation for problem solving activities
Maintain full awareness of current and future projects planned for the organization to provide strategic recommendations and direction
Excellent understanding of Quality Assurance and Testing industry best practices backed by a solid technical/development background (ability to conduct critical review of project deliverables, provide guidance & take action where necessary)
Skilled in building teams, training, coaching, facilitiating and developing employees
Proven ability to deliver detailed management information and interpretation of the results
Excellent organizational, analytical and forward thinking skills to coordinate complex delivery schedules, ambiguous, changing business drivers, competing priorities
Strong decision making skills to resolve conflicts arising over a wide range of competing projects and priorities
Demonstrated ability to effectively communicate and build strong working relationships at all levels within a large organization (business and technical)
Demonstrated ability to negotiate with and manage external vendors
Demonstrated ability to understand business models and risks

Director, Quality Assurance Resume Examples & Samples

Strategic Planning and Implementation
Work with senior leaders, global offices, and game development teams to develop strategic and operational plans, business processes, and workflows that align with the QA vision while cultivating healthy relationships that will ultimately guide the success of the department
Develop and deliver on annual goals and objectives for quality assurance that are measurable and time based
Implement plans to achieve these goals and cascade them across the department
Pioneer the next level of QA best practices for design and tech in the game industry
Continually seek methods to improve the effectiveness, efficiency, and partner satisfaction of QA
Deliver Effective, Efficient, and Expedited QA services
Significant focus on project test operations including reviews, budget, staff, resources, schedule, risks, roadblocks, etc
Ensure that all QA testing projects are executed to exceptional quality, on time, and within budget
Ensure that QA teams maintain excellent levels of communications with development teams and business partners
Maintain and Evolve a Large Scale High-Performing QA Organization
Manage, maintain, and evolve a world class testing organization
Ensure all roles and responsibilities remain accountable and clearly defined while sharing responsibility
Plan and fill all yearly staffing capabilities needed within the QA organization
Maintain, communicate, and execute an effective performance management program
Implement methods to ensure high employee retention and succession, especially strategic and critical positions
Inspire your department and stakeholders with a shared vision to broaden viewpoints on the role of QA as a partner
Develop, maintain and grow essential relationships with development teams and other strategic partners within the business
Assess new tools, processes, and capabilities to streamline workflow and reduce friction
Continue to evolve Blizzards quality assurance dept. as a center of excellence

Senior Program Director Quality Assurance Resume Examples & Samples

Bachelor’s Degree in Child Development or Early Childhood Education
Minimum of two years’ experience in Head Start or early education programs
Director qualified under Missouri Accreditation for 100 or more children
Understanding of Head Start content areas and Performance Standards
Demonstrated organizational and management skills and abilities related to human services
Experience working with children, families, and community agencies in an urban environment
Able to work with diverse groups of people in a friendly and consistent manner
Sensitivity to individuals representing a variety of family, cultural, and socio-economic backgrounds
Able to exercise high levels of discretion and confidentiality
Responsible for hiring, training, and supervising Head Start Program Directors and other associates as assigned
Act as a liaison between the Management Team and the Program Directors including relaying information and training Program Directors on new and existing procedures
Responsible for assuring compliance with quality assurance and program evaluation requirements
Ensure that funded enrollment is maintained throughout the program year
Develop and facilitate a positive community presence in the community, focusing on networking opportunities, enhancement of volunteer participation and education awareness and efforts in regard to program needs
Monitor Program Information Report (PIR), Key Performance Indicators, Monthly Compliance Report, and other ChildPlus reports consistently and work with center associates to update reports as needed
Work closely with People Services to assist in reviewing applications, interviewing, and selection of associates so that open positions are filled with the most appropriate candidate in a timely manner
Ensure that all center level associates has an up to date individualized development plan
Attend Quarterly ChildPlus meetings and others as needed
Provide training and technical assistance to associates on ChildPlus
Assist in responding to verbal and written complaints about the centers
Act as a gatekeeper for Delegate Management Systems and is responsible, accountable, answerable, and explainable to grantee for all levels of delegate system of ongoing monitoring, records, and reports
Facilitate annual Self-Assessment process, report writing, and program improvement plan, while working closely with members of the YMCA Management Team and Grantee Staff
Participate in and make recommendations based on the Community Needs Assessment information
Oversee the updating and implementation of the YMCA Head Start Operational Manual. Develop and maintain specific program policies and procedures to meet federal regulations and oversees the distribution and training on the manual to all associates
Coordinate the annual updating of the Head Start work plan, program improvement plans, strategic plans, and program goals
In conjunction with the Vice President and Management Team develop the training plan/calendar; family and associate calendars; that include reporting requirements, meetings, trainings, safety checks, and monitoring requirements and reviews
Act as a lead for coordination and oversight along with the Vice President of the content areas to ensure that policies and procedures are being followed
Adhere to the Head Start policies regarding code of conduct/ethics and confidentiality
Must support the mission of the YMCA and promote youth and family values including the role modeling of our core values of caring, honesty, respect, and responsibility
Prepare the annual Program Information Report for the Head Start Program
Monitor and approve applications for training funds and reconcile training budget
Assist in the development and monitoring of the annual budget so that goals are met and spending is done in an accurate and timely manner

Director Quality Assurance Resume Examples & Samples

7+ years experience IP Testing Management & Strategies
3+ years managing technical/testing resources
Strong experience in testing mobile applications across a wide range of platforms, devices and networks
Strong comprehension of Object-Oriented Programming
Strong comprehension of RESTful web services, SOA
Strong comprehension of Load/Performance testing
Skilled in Transact-SQL
Experience in testing other connected devices such as 10’ devices (App TV’s, DVD players, Gaming Consoles etc.)
Skilled in MS SQL Server and strong understanding of relational database concepts a plus

Director, Quality Assurance Resume Examples & Samples

An accomplished individual with 15-20 years of QA delivery experience preferably in the BFS (Banking & Financial Services) domain. Exposure to US banking and person to person payments will be a plus
Very strong leadership skills, which should be a combination of people and technical leadership
Extensive experience in QA delivery and should have managed big QA teams to deliver high quality products / projects
Ability to manage all aspects of QA life cycle and bring in best practices across disciplines like functional testing, automation testing, performance testing, user interface testing, security testing etc
Ability to manage the QA delivery at high level but also be hands on during specific situations
Strong quality focus, driving & motivating teams to achieve QA delivery targets under dynamic circumstances
Understanding & appreciating client specific requirements and demonstrate flexibility in addressing client priorities in dynamic situations
Strong in people management with the ability to guide, mentor and groom team members successfully
Very strong communication and presentation skills (written and verbal)

Director, Quality Assurance Resume Examples & Samples

Direct all aspects of Quality Assurance, using a well-grounded understanding of the Software Development Lifecycle (SDLC) and proven Software Quality Assurance processes and metrics
Drive the transition from manual testing to the use of automated tools (e.g. record/playback) and script-based automated testing
Manage the operating budget for the Quality Assurance team including off-shore QA activities
Lead signoff calls prior to release and post-mortems following deployments
Promote quality assurance programs, policies, processes and procedures to ensure that performance and quality of products conform to established standards
Promote and execute Quality best practices, tools, and methodologies
Define and report metrics on product quality
Participate in planning/design phases of testing projects and drive improvements
Leads quality planning activities for new product development
Leads risk management activities throughout the product lifecycle
Manage and communicate QA schedules at regular intervals, highlight risks and wins to the executive team, and alert leadership of any QA scheduling conflicts
15 years of combined project management, product development, and QA management experience around high-scale consumer products in a rapid-release cycle environment
Experience implementing web test automation frameworks (Selenium, SOAP UI, Cucumber, QTP etc.)
Experience testing applications for major platform, including web, iOS, Android, and Windows
Demonstrated understand of device capabilities and differences across platforms and OS versions
Demonstrated experience implementing QA best practices
Demonstrated strong leadership experience, ability to drive results with urgency, and collaboration and positive influence skills
Demonstrated experience in use of metrics aligned to corporate KPI's and benchmarks to drive process improvement
3 years programming experience in any of the web languages (Perl, PHP, Python, Ruby) or equivalent
Experience managing application submission process for all major app stores
10 years managing a staff of quality assurance engineers and analysts
Highly conscientious project management
Demonstrated professional experience with vendor management
Proven ability to work in a dynamic environment and adapt to shifting priorities while managing multiple simultaneous QA projects
Strong interpersonal and communication skills, including problem solving, decision making, written and oral communications, and ability to work effectively with diverse groups
Demonstrated ability to seek out, build, foster, and maintain productive relationships and networks
Bachelor degree in computer science, engineering or equivalent experience

Director, Quality Assurance Resume Examples & Samples

Lead and support multiple concurrent business development pursuits and RFP responses for large clients, such as identification, proposal development, contract/SOW development, resource planning and other pursuit activities, while working with the appropriate KPMG resources from other service lines
Lead KPMG team in delivery of services/completion of deliverables outlined in signed statement(s) of work while managing and adhering to KPMG engagement management and financial management policies
Develop and sustain trust-based relationships with Directors, Vice Presidents, and C-level executives
Develop and execute test governance framework and processes
Support customers in driving and completing testing projects including establishing project framework and processes while resolving issues and removing barriers to progress
Twelve years of experience in software development, testing, program management and analysis including Bachelor’s degree from an accredited college/university in technical sciences or information systems; PMP, ISTQB, CSM certifications are a plus
Well established track record of leading high-performing engagement teams that deliver high quality testing results while establishing/maintaining customer relationships at all levels including demonstrating successful business development and consulting capabilities
Demonstrated ability to build and lead teams of various size in delivery of services to customer including leading remote or offshore resources
Experience leading and developing internal practice capabilities and teams, contributing to testing methodologies/toolsets, developing thought leaderships/whitepapers, speaking at conferences and influencing the marketplace
Extensive functional understanding of end to end testing from system testing through user acceptance testing including hands-on experience with industry leading test management and test automation toolsets
Ability to travel extensively

Director, Quality Assurance Resume Examples & Samples

Managing daily operations and maintenance of PNA Quality Management System, including
Conducting regular quality review meetings with the respective Quality Managers of the various sales units
Communicating with internal and external parties to resolve quality issues in order to enable product release and disposition
Participating in the product planning stage for new ODM-sourced products and review documentation for completeness and appropriateness, and providing QA approval for top management review and approvals
Coordinating document and record control activities
Performing internal and external audits of ODM factories
Performing risk assessments of product designs and market failures
Reviewing and approving Corrective and Preventive Action Requests (CAPAs), Non-Conformity Reports (NCRs) and Customer Market Quality Complaints
Bachelor’s degree, required in a technical/science field, or equivalent combination of education and experience
Minimum of 10 years of work experience managing quality system process and procedures
Knowledge of US regulations pertaining to product performance and regulatory compliance
Experience in using quality management tools for process improvement, gauging effectiveness and validating/verifying design and manufacturing changes
Thorough understanding of quality assurance concepts and practices
Ability to interpret and apply regulations and compliance concepts
Attention to details
Familiar with test equipment basics and basic statistical analysis
Travel (domestic and overseas)
Occasional normal lifting or movement when reviewing products. No heavy lifting
Flexible and adaptable to take on additional responsibilities as appropriate
Business Travel – 10% Domestic / 10-15% International

Director, Quality Assurance Resume Examples & Samples

This is a hands-on role
Provide leadership to a group of QA engineers in an innovative and fast-paced environment: articulate a vision and lead the team in implementing it
Own and drive complex test strategies and sample data sets from the planning stage through execution
Work with product management to ensure requirements have testing plans and what constitutes alpha, beta, staging, and release candidates for key consumer-facing products
Use off-the-shelf, open-source, or custom built software tools as necessary to automate regression testing for different use cases
Manage a team of 5 to 8 QA engineers
Manage career planning, performance reviews, and human resources matters
Act as advocate for your team during resource planning activities
Build your team: recruit, hire, and train new QA engineers
Maintain a positive and productive atmosphere for the team to work in
This position is in Austin, TX

Director, Quality Assurance Resume Examples & Samples

Establish and maintain Quality Assurance programs, procedures, and controls to ensure that products and processes conform to established specifications and regulatory standards
Ensure that direct reports follow company guidelines and procedures, and regulatory requirements
Manages directly, or through reports, all production QA activities. Acts as advisor to direct reports, staff, and partners to help meet established schedules or resolve technical or operational issues
Determines and implements requirements for equipment, test methods and processes used for QA activities. Identify operational, equipment and procedural improvements to minimize product defects and cost
Formulates and maintains Quality objectives and coordinates objectives with Manufacturing and engineering teams to maximize cross-functional alignment
Works with Manufacturing and Quality Engineering to provide feedback to operations personnel regarding effectiveness of production/quality processes and provide feedback on product quality and reliability issues
Determines and implements change control requirements for the site in alignment with global procedures and systems. Align resources with business units and project teams to provide timely processing of changes
Plans, promotes, and organizes training activities related to product quality, reliability and regulatory compliance. Develops strategies to ensure continuous improvement in the ability to manufacture quality products
Maintains up-to-date knowledge in the techniques of Quality Assurance/Quality Control, Risk Management, and in the company products and process technologies
Interfaces across the organization to identify software validation needs and plans resources to support validation efforts
Provide CAPA ownership, individually or through direct reports, for timely, compliant and effective investigation/correction of identified issues
Manage department budget and headcount; identify resource requirements
Performs other duties and project assignments as assigned
A bachelor’s degree is required, preferably with an emphasis in science or engineering, and a minimum of ten years of experience within the medical device industry, or a combination of medical device and other related regulated environment experience
Effective working knowledge of FDA Quality System Regulation, ISO 13485, ISO 14971 and other recognized medical device standards
Ability to work and lead in a team environment. Ability to attract, develop and retain talented employees
Proven track record of producing results in terms of process, compliance and efficiency improvements
Sound analytical skills, including experience with problems of diverse scope that requires analysis of data
Ability to travel up to 15% of the time

Executive Director, Quality Assurance Resume Examples & Samples

Serve as a subject matter expert to guide the company on QA related issues by communicating proactively and effectively with the VP Global Regulatory Affairs and Quality Assurance
Develop, implement, maintain, and communicate the corporate quality strategy, quality annual plan and quality programs throughout the Company
Provide leadership in ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of company operations, processes and products
Ensure the Company is kept current with all new quality-related regulatory requirements, and provide guidance to senior management on the implications of any new or updated requirements
Maintain a world-class quality management system by directing, and providing oversight and input into the relevant quality systems and standards including: batch release and control; change control; document management system; quality procedures, standards, and policies; audits; product complaints and recalls; quality system reporting; investigations and CAPAs; and other related areas
Direct inspection readiness activities
Approve Quality Agreements
Coordinate activities and lead interactions during regulatory agency inspections
Adjudicate issues with compliance concerns
Qualification, auditing, and compliance oversight of Contractors
Schedule and supervise scheduled third-party audits by internal QA staff or external contractors
Development, tracking, and trending of Quality Metrics for contractor performance and product quality
Provide feedback to operational department heads regarding audits, plans, findings, CAPAs, and issue resolution
Lead and direct QA staff in the preparation of the quality components of global regulatory submissions
Ensure that the company and departmental SOPs, job descriptions, and training documentation are current and relevant
Responsible for ensuring appropriate review and approval of Master Batch Records, SOPs, Change Control Documentation, Product Labeling and Revisions, Audit Reports, Validation Documentation, Product Specifications, Analytical Methods, and Contractor Qualifications
Act as the subject matter expert (SME) for optimization of new or existing products, processes, techniques, procedures or facilities/equipment to ensure compliance with quality criteria
Prepare and review QA budget
Support the Company’s project teams and assist with project scheduling to assure that timelines and deadlines are met in the most efficient and economical manner
Provide regular updates and recommendations to VP Global Regulatory Affairs and Quality Assurance regarding the status of objectives, projects, and goals relative to quality compliance objectives
Hire, manage, support and develop/train QA staff and secure sufficient resources to support the company’s goals and objectives
Travel (domestic and international)
Maintains a performance and improvement culture
20+ years of experience in the pharmaceutical/ biotechnology industry
Minimum 15 years’ senior quality systems leadership in the pharmaceuticals industry
High level of familiarity with broad range of compliance areas and ability to assess risk and develop solutions
Ability to build and manage relationships with business partners
Strong proven hands-on experience with a variety of both GMP and GCP compliance matters and contractor management in the bio/pharma industry
Previous experience with building QA systems and company-wide SOP system
Extensive experience handling FDA inspections required
Proven ability to interpret regulations, to define and communicate strategy/plan to teams across multiple programs
Experience with multiple aspects of the product development (CMC, nonclinical and clinical)
Strong knowledge of US and other major global (ICH, EU, Asian) regulatory compliance requirements
Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
Understanding of scientific methods and the ability to interpret and communicate scientific data internally and externally
Ability to multi-task in a very fast-paced environment
Must be able to effectively collaborate with peers and comfortable working in a matrixed team
Must be solutions oriented and pragmatic (with analytical thinking and problem solving skills)
Excellent project management and organization skills is a must
Excellent communication skills (verbal and written) and interpersonal skills
Computer literate

Senior Director, Quality & Assurance Resume Examples & Samples

Ensure Quality Compliance System of OPKO pharmaceutical business units meet current GCP,GLP standards
Audit Quality Compliance system to assure adherence to written procedures
Assist in evaluation of compliance system of third party services providers in the areas applicable to the conduct of pre-clinical and clinical operations
Develop strategic audit plans for all programs, ensures audits are conducted in accordance with the plan, evaluates and drives CAPA(s) to closure in accordance with company standards and policies
Provide training and guidance to staff who have the responsibilities in the related functional areas
Manages and/or leads domestic and international audits for Clinical Investigators, Trial Master Files (TMF) and/or GCP document audits, document control procedures to ensure compliance to ICH GCP, applicable regulations, and company standards
Participates as a co-auditor for investigations into scientific misconduct and/or serious breach of GCP, analyzes investigational findings to identify root cause
Establishes procedures and to assures reporting of potential or confirmed violations, as appropriate, in accordance with company standards
Identifies and escalates critical quality issues appropriately
Provides inspection support as necessary for Regulatory Agency inspections held at OPKO Health facilities or Clinical Investigator sites
Accountable for the Document Control function and management of QA Controlled documents including maintenance of the QA Document Archive
Responsible for the supplier qualification program, ensuring site audits are performed when needed, reviewing audit reports/observations and evaluating issues with suppliers
This position will require domestic and international travel
This position is located in Miami, Florida. There are no telecommuting options
Bachelor’s degree in scientific or allied health field. Advanced degree strongly preferred
Minimum of nine years of relevant GCP QA work experience, or relevant comparable background and 5 years of relevant GCP QA experience with new drug development experience
Must be able to organize and prioritize work effectively to meet timelines with quality deliverables
Possess the necessary scientific education and knowledge to manage and provide quality oversight for GCP, GLP studies, understands medical terminology, standards of care and disease states to assure the ethical treatment of subjects
Demonstrated proficiency in managing complex projects and proactively communicating changes in pre-established goals and deadlines
Proficient in using Microsoft Office applications is an asset (MS Word, MS Excel, MS PowerPoint) as well as clinical data management programs

Director, Quality Assurance Resume Examples & Samples

Lead a test organization of at least 20 Associates, in multiple locations, across multiple time zones both on and off-shore within the Quality Assurance organization
Plan and execute test activities, both manual and automated, in support of multiple project releases ensuring high levels of quality and commitment to deadlines
Promote innovative quality assurance strategies and methodologies throughout the organization with an emphasis on automation
Develop, implement, communicate, and maintain plan to bring quality assurance process into compliance with Industry best practices
Mentor and coach management staff
Effectively interact with project team members to ensure on time, high quality delivery of Financial Risk and Financial Control Solutions product releases
Collaborate with QA Managers and QA Engineers to define, develop and implement overall automation test strategies, methodologies, processes and metrics collection
Building and maintaining reusable automation framework for Functional and Regression testing
Ensure compliance with national and international standards and legislation
Job-Related Experience
15+ years of technical experience in either Development or Quality Assurance, including experience as a Quality Assurance test analyst/engineer and a test automation engineer. Expertise in decomposing functional design specifications for test planning and test case development and expert knowledge of the multiple phases of testing including; functional, system, integration, end-to-end and user acceptance testing is a must in addition to utilizing those skills to develop a test automation process
10+ years of progressive technical leadership/management experience, involving people resources, hardware, software, and services experience
Experience utilizing performance testing tools and techniques as part of overall test strategy
Experience working with multiple test managers to schedule test automation activities
Effectively utilizing test environments to support multiple projects and releases during various stages of software deployment from development through to production
Previous experience in Financial Industry specifically in payment industry and transaction processing is a plus
Proven track record of effectively leading test automation, environment and performance testing teams located in multiple locations
Direct experience managing off-shore teams
Direct involvement in implementing and improving an Agile Development methodology in one or more organizations
Proven track record of significantly improving overall technology quality/testing methodologies across the enterprise
Well versed in all testing methodologies, tools, and processes
Advanced knowledge of the organization, industry, and quality assurance best practices
Excellent business and technical communication skills, including verbal and written
In-depth knowledge of IT hardware, software, and services
Strong leadership abilities, including the ability to accept responsibility and challenges, developing new and/or refining existing methods/processes, using good judgment and sound project management techniques, and taking ownership for decisions

Director Quality Assurance Resume Examples & Samples

Managing and Communicating Performance
Acquires data, information and updates for quality metrics for Quality, Operations and Commercial area reporting
Ensures teams are driving to key metrics/goals and provides/pursues needed resources (e.g. human, equipment, etc.) to meet objectives
Ensures appropriate Quality information is communicated to the business
Establishes and maintains budget
Building Strong Work Relationships
Interfaces with team members, colleagues and leadership in a professional, productive and trustworthy manner
Constructively resolves/addresses conflict
Responsive to stakeholders
Cleary communicates messages that are productive and straightforward
Is easy to do business with, removes obstacles
Encourages and supports the generation of new ideas that drive business value
Collaborates with other Leaders to ensure initiatives, activities, programs and objectives are aligned
Develops/mentors employees
Providing Relevant Expertise and Analysis
Analyzes data to make fact-based recommendations/decisions and help determine solutions
Guides in development/implementation of processes/initiatives that support the project goals and maintains compliance to applicable standards, regulations, procedures/policies
Contributes benefit of personal experience and knowledge to the project/business
Continuously looks for better ways to enhance our processes, services or products
Systematic problem solver
Escalating Issues
Anticipates/identifies areas of concern and brings them to the appropriate personnel in a concise and actionable manner at the appropriate time
Provides details as needed on the issues
Follows up on issues to drive/monitor resolution
Ensuring Compliance
Maintain audit readiness regarding all policies, procedures, and documentation standards
Knowledgeable of relevant/important regulations, standards, procedures/policies internally and externally
Carries out duties in compliance with all government regulations and Company procedures/polices
Minimum of 8 years in a regulated industry with at least 3 years in Quality profession. Prefer knowledge of the medical device industry
Thoroughly knowledgeable of Quality principles and practices as well as regulations and standards
Proficient in Microsoft Office applications: Excel, Word, and PowerPoint

Director Quality Assurance Resume Examples & Samples

Lead implementation of Quality System compliant with applicable regulations
Overall responsibility for the quality plan and quality systems for the FMI Penzberg site
Quality liaison for any technology transfers that take place in Germany, Switzerland and/or Austria
Quality liaison with FMI QA group for DACH countries
Work with the Clinical Laboratory Director and US QA Director to review all Quality documents for regulatory compliance
Demonstrate strong proficiency in the application of the Corrective and Preventive Action system, to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources
Provide QA oversight for materials management program and sample inspection process for all incoming materials
Review batch record for final release activities
Generate and report required Quality Metrics and data for Management Review to meet regulatory requirements
Provide supervision of QA associates/specialists as applicable
Ensure proper management of deviations and non-conformances
Responsible for maintaining, updating and versioning of policies and protocols
Ensure that record keeping is performed in accordance with good documentation practices and are attributable, legible, contemporaneous, original and above all, accurate
Ensure that equipment used for specimen testing are properly maintained, cleaned and inspected on a routine basis per SOPs and in accordance with applicable regulations
Manage IQ/OQ activities of new equipment and oversee PM/calibration activities
Responsible for ensuring that equipment standards are tested, calibrated and standardized before patient testing, and that all must be documented and approved
Provide routine review of incident and deviation logs
Manage employee training files
Review credentials to ensure compliance
Manage training matrix

Director, Quality Assurance Resume Examples & Samples

Responsible for delivering key Quality, compliance and business results through managing subordinate Site Quality Assurance leaders
Ensures alignment of Quality programs within the COE (centre of excellence) strategies for the site(s)
Ensures appropriate quality systems and organizational structures are in place to meet quality expectations and business needs
Provide SGS quality leadership with periodical quality performance assessment for each manufacturing site
Ensure that there is effective and timely communication of product quality issues to ensure the mitigation of risk
Ensure that the site’s conformance and commitment to quality meets or exceeds customer requirements and the relevant regulatory standards
Sponsors an environment of compliance within Stryker by working with business partners to define and maintain expected quality standards
Champions a positive employee environment by promoting open communication, engagement and development of team members. Promotes a culture of trust, flexibility, teamwork and inclusiveness
Ensures effective processes in selection of competent talent and supports the development of future potential experts and leaders. Ensures effective training and performance management processes are in place and executed
Ensures the site(s) maintain continued certification to all regulatory bodies. Sponsors and ensure engagement in all internal and external audit programs such as Corporate, notified body & FDA inspections
Foster collaboration, develop partnerships, and participate in multi-disciplinary Quality teams across the region and with all internal and external stakeholders to shares best practices with other regions/sites
Leverage shared services and drive common processes to improve quality and reduce cost
Ensure deployment and exchange of regional talent and leverage geographic synergies
Ensures effective management and control of product/process deviations and implementation of effective corrective and preventive action

Director / Senior Director Quality Assurance Resume Examples & Samples

Establish and maintain a risk-based and scientific-based quality system
Approximately 30% Domestic and International travel
Through a quality system approach, ensure all GCP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence
Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development as appropriate
Oversee and be ultimately responsible for quality assurance program; this includes overseeing and assisting with training and auditing programs, as well as the review of SOP’s, investigations, validation reports, pharmacovigilance and AE reporting
Prepare, review and approve external and internal reports and other documentation required by regulatory agencies, customers or to support the quality assurance function. Provide support and training to other staff members to develop additional auditing resources
Act as company’s representative during regulatory agencies and customer inspections
Identify and lead operational excellence initiatives, both in the department and companywide, which result in the overall improvement in both areas
Partner with colleagues in other departments to increase the overall effectiveness of the Quality department
Audit the facilities vendors, customers and outside contract organizations
Full understanding of GCPs and pharmacovigilance
A good understanding / familiar with GLPs and cGMPs
Understanding of FDA inspection procedures
Experience with Phase I thru IV, particularly Phase III; experience with Regulatory approval, NDAs and MAAs
At least 10 years of QA experience in regulated industry such as pharmaceutical, biologics or device
Experience with effectively managing FDA inspections, working with regulators, and vendor audits
Broad knowledge of risk based quality systems approaches

Director, Quality Assurance Resume Examples & Samples

Establishes and maintains Quality System procedures and controls ensuring that performance and quality of the product conforms to established company and regulatory standards
Develops and disseminates strategy for talent attraction, development and retention to enhance the Quality Operation talent pipeline
Provides active link and partnership between the sites, franchise partners, regions and corporate functions
Partners with the respective management for their sphere of influence to develop and support initiatives and responses to internal issues
Executes responses to field actions and coordinates global response with the franchise Quality leadership and corporate functions
Ensures site assesses Quality System effectively through internal audit and Management review and implements corrective/ preventive, improvement actions as appropriate
Ensures site address customer feedback and complaints in appropriate and timely manner
Ensures that the site’s implementation of Quality Systems and goals are integrated in a cost effective and productive manner
Establishes and monitors metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness and value to the business
Leads the site staff in the understanding, development and deployment of key strategies, continuous improvement and customer focus
Supports the site in the investigation, evaluation and implementation of actions to eliminate root causes of non conformances
Possesses the necessary independence, authority and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product
Ensures appropriate resources with the right competencies to execute the Quality System
Reviews and participates in personnel development programs necessary to provide employee movement through prescribed promotional patterns
Evaluates and recommends staffing requirements to insure maximum utilization of personnel to fulfill department objectives
Approves salary increase recommendations and recommends salary increases and promotions for direct subordinates, interviews applicants for job openings, conducts performance reviews and provides guidance to subordinates
A minimum of a Bachelor degree is required. An advanced degree is preferred
A minimum of 10 years of overall related business experience in a healthcare regulated environment is required with the preference experience in drug and/or device related industries. A minimum of 5 years of direct report people management experience is required
Regulatory compliance knowledge and skills are required. Advanced Quality Systems knowledge is required. Product knowledge is preferred. Interpretation and application of QSR and ISO Standards are required
Knowledge of lean manufacturing and manufacturing processes such as Just in Time (JIT), KANBAN, and Pull Systems are preferred
Excellent communication and interpersonal relation skills are required. Statistical and analytical problem solving skills are required
The ability to influence at senior levels and across functions building strong networks internally and externally is required. Strong experience and proven record motivating leading and developing staff, in a highly changing environment is required. Change management skills are strongly preferred
Prior project management experience is highly preferred
An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset
This position will be located in San Angelo, TX and require up to 15% of both domestic and international travel.Quality Assurance

Director, Quality Assurance Resume Examples & Samples

Minimum of 10 years QA experience or relevant experience in clinical quality management, biomedical science, clinical development, or regulatory strategy
Minimum of 5 years of leadership experience, i.e. project teams, line management, etc. with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
Proven business management capability

Director Quality Assurance & Operations Excellence Resume Examples & Samples

Develop/oversee the CASS program so that it is effectively identifying and addressing compliance risks to ensure regulatory compliance
Ensure that the CASS program effectively assesses short- and long-term impact of proposed program, policy or philosophy changes in the Tech Ops Organization
Monitor and manage non-compliance events, follow-ups, and associated process improvements
Develop/manage measures to identify risks and drive new CASS projects (related to compliance issues, programs, etc.)
Lead the Manual Revision Committee for Technical Operations
Coordinate CASS briefings to provide CASS performance to Senior Staff and FAA, as required
Develop and oversee the implementation of Safety Management Systems (SMS) within TechOps
Establish and maintain liaison with the FAA (local, ACO, etc.) and other regulatory agencies on all matters pertaining to CASS/SMS initiatives
Stay informed of changes and requirements of the Code of Federal Regulations (CFR), advisory circulars and FAA guidance
Oversee audits of all company maintenance and engineering operations and outside maintenance and other applicable vendors
Oversees and monitors compliance of Airworthiness Directives, Federal Aviation Regulations, and manufacturers' service bulletins, as applicable to aircraft structures, systems, instruments, components, appliances, engines, and auxiliary power units for compliance
Champion operational excellence projects throughout Technical Operations
Support process improvements through OpEx program initiatives and delivery of Lean/Six Sigma training
Undergraduate degree in Engineering or equivalent experience/training
At least 10 years airline maintenance experience
FAA interaction experience
Experience leading complex, cross-functional teams/projects
Experience and understanding of airline technical operations business processes and systems
Leadership experience at the manager level
Safety / Airworthiness investigation and evaluation experience
Experience in data gathering and analysis
Demonstrated knowledge of most, if not all, of the following areas
Maintenance programs, policies and procedures
American Airlines Corporate Policy
Airworthiness Directives, TSOs and STCs
Code of Federal Regulations (CFRs)
FAA policies, procedures and documents
Management techniques, leadership skills and project management
Vendor documentation (AMM, IPC, WDM, CMM)
Ability to work well under pressure, meet deadlines, and maintain the highest regard for safety
Experience preparing and delivering executive-level presentations (including business cases)

Director Quality Assurance / Quality Systems Resume Examples & Samples

Developing job descriptions and hiring Quality workstream leads
Project management for all Quality workstreams
Excellent understanding and practical application of medical device quality system regulations
Must be able to develop a quality system leveraging existing Siemens procedures while integrated CFDA requirements and best practices learned from prior experience
Experience hosting/participating in FDA and Notified Body inspections
Prior experience with facility start-ups and quality system implementation is a plus
Must be able to work collaboratively with other Core Team leads
Quality system auditing experience
Prior experience in an IVD manufacturing environment is preferred
LI-LRP

Director, Quality Assurance & Systems Resume Examples & Samples

Ensure divisional achievement of quality targets
Provide a strategic direction and tactical focus to the Quality Assurance organization and the Joint Replacement division
Oversee effective utilization and understanding of Quality Assurance systems in our regulated environment
Provide strategic direction to and tactical interaction with Stryker Global Supply affiliates supplying the Recon division
Provide a platform for process improvement through the training and utilization of Lean/Six Sigma methodologies
Serve as alternate management representative in the absence of Vice President, CQR

Director, Quality Assurance Resume Examples & Samples

Bachelor's degree in a technical field (such as Engineering, Computer Science or Quality Management)
Requires 8 - 10 years QA experience, including 5 years in a Quality leadership role
Experience on Desktop/Mobile and Services/Cloud
Strong understanding of quality assurance testing tools and methodologies including automation
Ability to motivate others and lead toward successful goal completion
Able to provide thought leadership on Quality Assurance and Quality Engineering concepts
Excellent leadership and communication skills necessary to implement policy and initiatives
Demonstrated expertise in quality and process improvement systems
History of implementing best practices across multiple areas of software testing
Familiarity with our technology stack and tools (or something comparable)
Atlassian tools (Jira, Confluence, HipChat, Bamboo, etc.)
Test Frameworks and tools e.g. xUnit, Selenium, Sikuli, Mocha etc
TDD, BDD and tools e.g. SpecFlow, Cucumber etc
Tech stack: C#, AWS
Mobile tech stack: Xamarin, iOS
Infrastructure: VMWare

Director, Quality Assurance & Food Safety Resume Examples & Samples

Bachelor’s degree in food science or equivalent
Advanced knowledge of applicable federal, state and local food, beverage and personal care QA laws both domestically and internationally (i.e Food GMPs, SOPs, HACCP/Food Safety, and Environmental Guidelines)
Experience with quality assurance of dietary supplements and/or OTC is a plus
Experience with regulatory requirements at manufacturing level, specifically organic & Kosher certification is a plus
Ability to travel a minimum of 25%
Export experience is a plus
Ability to organize extensive paperwork necessary to process the flow of ingredients and finished foods with proper attention to micro and nutritional testing results
Advanced understanding of quality control audit practices
Knowledge of manufacturing machinery capabilities and associated quality testing techniques
Experience with interpretation of statistical reports and data for measuring quality control effectiveness
Excellent organizational skills, ability to prioritize multiple priorities and strong attention to detail
Computer skills including MS Office programs such as Outlook, Word, Excel PowerPoint
Strong interpersonal skills and ability to communicate (verbal/writing) effectively
Self-motivated and strong analytical / problem solving skills
Ability to collaborate at all levels of the organization and across other functional areas
Ability to maintain a high level of confidentiality
Preferred knowledge of the Consumer Product Goods Industry
Work with minimal supervision execute for results in a fast paced environment
Ability to empower, motivate and inspire staff
Previous supervisory experience a plus
Conflict resolution skillsEEO/AA/M/F/Veteran/Disabled

Director, Quality Assurance / Maintenance Resume Examples & Samples

Direct the development and implementation of Ryder’s quality assurance programs and policies, recommending revisions where necessary
Lead the quality organization
Ensure maintenance of the continuous audit programs which assure branch operations activities are conducted in accordance with company regulations and applicable Department of Transportation (DOT) regulations
Establish and direct administration of the supplier control system and monitor outside repair vendors, new vehicle manufacturers, fuel suppliers, and storage facilities
Manage the internal evaluation program, certification of branch operations, maintenance and servicing facilities, and continuous audits of the functional systems and related procedures in maintenance, technical services, and staff support organizations
Maintain liaison with the DOT and other regulatory agencies of maintenance related matters
Represent the company at industry meetings or on industry committees related to quality assurance issues
Direct the development and implementation of communications, plans, and programs to support corporate objectives
Consult with and influence senior management at various levels in and across a wide variety of functions
Incorporate quality concepts and human factor techniques in the design of organizational operations
Design experiments (analysis of variance techniques)
Perform quality cost analysis
Conduct reliability and safety system reviews

Director Quality Assurance Resume Examples & Samples

Establish the strategic direction of the Quality Assurance functional area with a focus on continual improvement and compliance
Provide Leadership to maintain a business wide culture of quality and work collaboratively to set quality strategic direction
Ensure an appropriate work force planning (5 years ahead) for the department. Manage the resource requirements and budget for the Quality Assurance function to optimize productivity and compliance
Direct responsibility for core quality systems
Process Release and rejection process
Deviation, CAPA Management & Product Recall
Quality Oversight of Manufacturing Operations
Actively support and participate in Quality system improvements, some of which may be led by others
Ensure efficient communication of required information to all appropriate customers. Escalate critical issues to the Head of Quality
Maintain, assess and communicate to the business the KPIs from within the release, deviation/investigation, Operational groups to ensure the effectiveness of their systems
Develop staff through training, education and execution of development plans to ensure employees are appropriately trained to execute their jobs and develop their behaviours, attitudes and competencies required to optimize their productivity and contribution
Liaise closely with key departments to ensure smooth execution of the processes

Director Quality Assurance / Internal Audit Resume Examples & Samples

Uses knowledge of industry standard testing methods and tools to recommend and implement new testing approaches
Works closely with software development staff and leadership to obtain tools and build the infrastructure necessary to sustain the tools and methods needed to facilitate repeatable, reportable testing processes. Works closely with the development staff management to ensure a smooth transition from the unit testing environment to the quality assurance testing environment. Provides feed back to the development staff management regarding the amount of errors found in the program code during QA testing
Thoroughly learns business applications systems within the business department; research and respond to application inquires
Works with leadership to establish the appropriate testing organization, including resource allocations

Director Quality Assurance Resume Examples & Samples

Bachelor Degree required, preferably in Engineering or Physical Science. MS Degree is a plus
Ten to fifteen years of overall manufacturing industry experience, with five to eight years of overall quality management experience. Job progression should be from technical, design or process engineering into quality, and into a management role
Experience with Commercial Airline Seats and of highly engineered aircraft interior products for aerospace applications is highly desired
Excellent written and verbal skills are mandatory
Experience with and oriented toward metrics in business analysis
Experience with SPC, data collection and analysis
Experience with having obtained an ISO 9001 and AS9100 certification is desired
Experience working with manufacturing based technology, processes and principles
Minimum five years in a Lean enterprise manufacturing environment
Advanced composites manufacturing experience preferred but not required
Ability to multi-task, follow through and meet deadlines

Director, Quality Assurance Resume Examples & Samples

Lead the team to develop, establish, and execute quality assurance measures and testing standards for new applications, products and/or enhancements to existing applications throughout the appropriate Software Development Life Cycle
Employing best practices, the leader will train and coach Quality Assurance associates in the appropriate application of recognized methods, including but not limited to
Establish Quality Principles and Concepts - Test protocol management/ Scenario creation
Establish Quality Baselines & Metrics - Target date management, Estimate creation and Performance measurement
Establish Quality Assurance - Requirement and design management/ Quality and Test Planning
Establish standards and processes around Business Acceptance Testing
Responsible for regression testing, integration testing, performance testing and business acceptance testing
Work closely with other stakeholders to ensure that testing functions meet their requirements and are delivered with high quality
Manage offshore and remote teams
Drive continuous improvement to the Quality Assurance teams
Ensure that all testing teams meet internal audit requirements for process and documentation in both an agile and waterfall processes
Provide sound decision making for quality assurance, sensitive to the constraints and needs of the business
Participate in all relevant meetings: Development Meetings; Project Team Meetings, others as assigned. Assume a leadership role in these meetings as needed
Participate in all corporate training, company initiatives and performance planning exercises
Other duties and special projects as assigned
8+ years of Quality Assurance experience managing software development projects
5+ years of driving test automation initiatives
5+ years of delivering enterprise QA metrics and track record of improving overall quality
Strong understanding of Software Development Life Cycle (SDLC)
Excellent Quality Assurance/Testing skills
Minimum of 5 years of experience succeeding in a leadership position with excellent leadership skills including the ability to mentor and coach associates to success
Demonstrated ability to identify, develop and implement process improvement initiatives and lead associates through change
Excellent verbal and written communication skills, including the ability to bridge the gap between technology and business
Excellent analytical skills and problem solving skills
Proven ability to manage remote teams
Proven ability to manage multiple projects
Experience with mobile testing is highly desired
Previous experience moving from waterfall to agile processes is desired
Demonstrated presentation skills required
Demonstrated leadership skills are required
Ability to build relationships with internal and external customers
Driven
Adaptable
Decisive
Capable of learning and growing with the company
Comfortable with visibility in a fast paced environment

Senior Director, Quality Assurance Resume Examples & Samples

Develops, implements, maintains and continually assess a regulatory and quality assurance function and a quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements, including but not limited to the following tasks
Develops and maintains Master Control (EQMS) system for procedures, work instructions and forms
Develops and implements appropriate quality training
Formulates and administers policies and standard operating procedures (SOPs) relating to the quality assurance function and the quality management system
Uses incident and Corrective and Preventive Action (“CAPA”) activities and processes to drive quality improvements and respond to process and service issues
Implements, performs and oversees internal quality auditing (including applicable vendors or subcontractors), customer quality audit response, and other quality management system activities
Guides the development of all quality assurance activities and quality management system processes
Ensures applicable services are “inspection ready”
Maintains quality through internal and external inspection of raw materials, finished items purchased and production operations and processes
Responsible for planning and directing quality control programs involving inspection methods, devices and controls
Defines, develops and implements short-term and long-term strategies, goals, objectives and tactics relating to the regulatory and quality assurance function and the quality management system
Reviews and recommends appropriate corrective action to ensure consistency with the regulatory and quality assurance function and the quality management system
Implements a continuous improvement plan for growing and maturing the regulator and quality assurance function and the quality management system, including the following tasks
Performs periodic internal quality management system reviews and audits
Designs and develops key quality, compliance and performance indicators
Designs, develops, implements and enforces best practices, processes, guidelines, systems, and technology to support and enhance the quality assurance function and the quality management system
Analyzes performance of quality assurance function and quality management system activities and documented resolutions, identifies problem areas, and devises and delivers solutions to enhance quality control and prevent future issues
Keeps the lead team apprised of quality assurance issues as needed
Represents quality assurance function and quality management system and related processes in connection with internal or external audits, inspections, monitoring visits and new business development activities, and assists with quality-related information related to (but not limited to) client assessments, RFPs, contracts and other documentation
Maintains current knowledge base of regulations, corporate policies and standards to ensure that the regulatory and quality assurance function and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices
Directs all departmental budgets and goals for QA and the Regulatory Department
Manages government interactions requiring governmental approvals, liaison with the Health Canada
Acts as expert and provides inputs across other ABC entities as required
Perform related duties, as assigned
Extensive knowledge of pharmacy automation, pharmacy operations, medical device manufacturing and quality control systems
Demonstrated leadership skills for multiple, large capital projects
Strong interpersonal skills; ability to develop and maintain cooperative working relationships with others

Senior Director, Quality Assurance Resume Examples & Samples

Develop and implement vision and strategy for a transformational total quality management system (QMS) approach for manufacturing plants including systems, processes, technology, programs, people training and communication
Evaluate existing organizational and programmatic elements of TrinityRail Maintenance Services quality control, quality assurance and compliance and develop a roadmap to execute the vision and strategy
Establish and embed a quality culture mindset throughout the organization and partner with production, supply chain, and engineering
Establish objective evidence and criteria to comply with government regulations, state requirements and regulations and Trinity requirements
Ensure compliance with applicable internal and external regulations, standards, policies, and procedures related to the quality and regulatory status and performance of company operations, processes and people
Initiates and implements quality improvement activities as appropriate (e.g., Kaizen, Six Sigma) to raise the performance of the company’s product lines
Educates and trains employees as to their impact in the quality management system
Serves as the primary quality control resource for problem identification, resolution, loss reporting and continuous improvement
Manages quality control personnel on a day-to-day basis
Supports concurrent engineering efforts by participating in design development projects representing quality assurance and the customer
Establish and implement metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and to enable managers to make sound product quality decisions
Performs root-cause analysis and other problem solving activities to identify effective corrective actions and process improvements
Establish collection and analysis systems of statistical data to predict trends that will affect improvement of product quality
Analyzes customers’ product specifications to establish efficient, cost-effective requirements for ease of manufacture and reproducibility
Develops quality planning methods for all product lines
Develops process certification standards and assist in process certification
Monitors vendor performance and establish criteria and rating system for critical vendors
Reviews customer purchase orders, contracts and change requests and ensure that the necessary criteria and provisions are included in quality and process plans
Interacts with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel
Reviews suppliers purchase orders and establish supplier quality requirements
Interfaces with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented

Ntess Director Quality Assurance Resume Examples & Samples

Develop and assure compliance with the Corporate Quality Assurance Plan and provide consistent application of quality management principles to enable the Laboratories? mission, vision, and strategy while satisfying customer requirements
Revises and updates the Quality Manual
Oversee and direct the overall quality direction of the corporation and the effectiveness of the quality management system
Developing corrective actions to support quality assurance problems and failures, suggesting modifications and corrective actions by site organizations to meet customer specifications and standards
Administer an Issues Management System that provides ability to track issues and provides information that enhances proactive preventive corrective action
Oversee the Corporate Policy System Policies, Processes, and Procedures as it relates to Quality Assurance
Promote enhanced Quality partnership with other functional organizations
Maintain a quality assessment system to monitor customer objectives
Create and sustain a culture that is based on continuous improvement
Develop and maintain plans for Third Party assessments across the Laboratory
Validates all engineering change notices
Develops and maintains a site quality index, using statistical control programs, using predictive measures to prevent potential quality problems
Take lead responsibility for significant quality issues. Be ?hands on? with the issue, develop a plan to resolve the issue, communicate the plan and progress on the plan to the organization
Utilize a Risk Management system to identify risks and take actions that mitigate or prevent the risk from occurring
Assures support for external audits and implementation of any required corrective action
Identify areas where product or service quality requires corrective action
Implement a lessons-learned system, including tracking of corrective and preventive actions; integrate findings with CAS
Directly supervises employees and performs other managerial responsibilities including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
Conducts activities in a safe and healthy manner and works in accordance with established HS&E requirements to ensure the protection of employees, the public, and the environment. Takes actions necessary to "stop" work when an unsafe condition or action is identified. Every employee has the right and responsibility to stop work when unsafe conditions or actions are identified
Demonstrates a confident and well-developed communication style, both written and spoken, that establishes credibility and facilitates clear understanding of contractor assurance issues and influences change where appropriate
May take on additional increases in scope based on future business need, including managing special projects
Bachelor's Degree in Engineering, Scientific or Business discipline
Minimum of 12 years progressive experience in Quality, Supply Chain, and/or Engineering including at least 2 years management experience and 3 years in Quality
Minimum of 2 years working in a government contract environment
Current or previous employment at Sandia Labs
Ability to travel up to 25%
Excellent communication skills (written, verbal, public speaking) are required
Demonstrated history of effective communication and cross functional collaboration with a broad range of diverse audiences (customers, suppliers, engineering, test & evaluation, integrated supply chain and program management)
Possess the ability to effectively communicate with all levels of management, both internal and external, and with staff at all levels, with customers, and sponsors
Strong analytical and problem-solving skills
Self-starter with the ability to operate independently in an ambiguous environment
Integrative thinker with demonstrated ability to solve complex, multi-faceted problems with due consideration for business and strategic consequences
Ability to gather, synthesize, and interpret counterintelligence data and turn into compelling messages
Advanced technical degree/MBA preferred
Experience leading management operating systems
Leadership innovation and ability to think strategically
Leading multiple teams to achieve cross-functional objectives
Experience utilizing risk management as a proactive management practice to prevent quality issues
Experience leading change or transformation initiatives
Demonstrated successful project management leadership
Experience establishing operational metrics and key indicators for process control, communication, and performance improvement
Strong leadership, communication, and business partnering skills along with excellent negotiation and problem resolution
Black Belt and/or Lean Certification

Director, Quality Assurance Resume Examples & Samples

Management of the operations of a diverse workforce including quality technicians, analysts, shipping and receiving
Responsible for ensuring the effectiveness and efficiency of the processes utilized within the manufacturing arena
Assist with the manufacturing effort to ensure that products are produced effectively and efficiently and with appropriate level of quality and integrity
Ensure compliance with applicable military and industry standards and specifications
Recommend and assist in the implementation of continuous improvement initiatives
Responsible for developing, implementing, and maintaining ISO9001/AS91000 programs as well as specific procedures and the adherence thereto
Oversee the Statistical Process Control program
Manage the Customer Furnished Property Control program
Perform long range planning to assure work flow and manning are balanced as effectively as possible
Review contracts and purchase orders for quality requirements
Perform on site evaluations, surveys and audits of vendor and sub-contractor quality systems, and production capabilities
Review designs, engineering changes and related documents for conformance to quality requirements
Prepare letters, reports, presentations and briefings on quality-related matters for customers and management
Interface with customer Quality Assurance Representatives for scheduling of shipments, quality audits, and corrective actions
Compile Failure Analysis Reports
Act as Government Industry Data Exchange Program (GIDEP) representative
Monitor calibration schedule of all inspection/measurement equipment
Approve parts list requests
Conduct Internal Quality Audits and monitor corrective action
Must be at assigned worksite during assigned hours 100% of time; less PTO, FML/STD/LTD
Interface with customers and suppliers as necessary
Create and maintain files, records, vendor histories, etc., as required
Supervise and evaluate the job performance of the Quality Technicians, Data Analysts, Quality Engineers, and Shipping & Receiving employees
Coordinate personnel actions with the General Manager, Human Resources Manager, and other department managers, as required
This position is responsible for managing the Quality Technician(s), Quality Engineer(s), and Shipping & Receiving Manager
8 years managing in electronics manufacturing may be substituted for degree
20/20 vision and color vision with or without corrective lenses

Director Quality Assurance Resume Examples & Samples

Requires a BA in related field and 5 years business management experience leading teams involved in quality, audit, with working knowledge of management benchmarking, outcome measurement, quality management, and business analysis; or any combinations of education and experience providing an equivalent background
Practical experience implementing valid statistical sampling programs required
Quality program development experience required
Health or Dental insurance experience preferred

Director Quality Assurance Resume Examples & Samples

Prepare and conduct executive level presentations/briefings at managerial level reviews with LM executives, tracking action items to completion, and providing data to SSC and Corporate when requested
Identify and develop high potential talent within the QA discipline including the establishment of a robust QA succession planning across all programs
Partner with key organizations to organize and execute important events, such as all-leadership meetings, VP and executive staff off-sites, tiger teams, etc. with high-level impact and in support of business needs
Work with the leadership and communications team to develop internal program-level communications, engagement and recognition initiatives
Create metrics and measures to monitor progress and capture best practices and successes for executive level reviews to be used across the enterprise
Minimum of 10 years of Program, Operations, QA or Engineering experience
Minimum 7 years of management experience leading increasing size of multi-discipline/site teams with demonstrated leadership experience
Bachelor’s degree from an accredited college in technical discipline (e.g., engineering field) or equivalent discipline (e.g., math, physics, chemistry, etc.)
Proven experience working with executive level leadership and creating high-level briefings and presentations
Project management experience across organizations
Must demonstrate Full Spectrum Leadership behaviors
Prior experience with DOD or Aerospace
Master’s degree in a technical field
Six Sigma or Lean Processes certification, lead auditor, metrics and statistics background
Proven self-starter and self-motivator
Experienced big picture thinker with proven strategic project management skills
Demonstrated experience with quality assurance across the life-cycle of a program
Demonstrated knowledge of SSC Major Functional Organizations’ initiatives for commonality and productivity improvements
Familiarity and working knowledge of SSC Quality Management System and AS9100 standard
Prior Space experience
Prior Production experience

Director, Quality Assurance Resume Examples & Samples

Computer science or related field with 5+ years of relevant management experience and at least 3+ years of experience as a people manager leading teams. Significant Enterprise IT and virtualization (VMWare, Azure experience is a must)
Proven track record to creating and executing on highly effective quality processes within an agile product development environment
Has in-depth knowledge of both UI and backend service test automation with view to operational processes
Able to handle an extremely fast pace while maintaining the highest quality standards
Has experience and conviction around measures to quantify software quality
Advanced degree in computer science or related field with 7+ years of relevant experience and at least 5+ years of experience as a people manager leading teams of individual contributor and leads
Is experienced with scrum and Scaled Agile Framework
Experience managing quality assurance teams of 6+ people who are geographically dispersed
Experience with a number of different programming languages and test automation technologies as plus

Director Quality Assurance Resume Examples & Samples

Ensure there are product quality programs in place to guarantee food safety and product quality, which will include an effective updated program at all company owned facilities and co-packer facilities
Update Plant Food Safety Plans from HACCP- based to FSMA’s HARPC compliance. This includes conducting hazard analysis, identifying and developing CCP,s Process Preventive Controls and Prerequisite programs
Monitor the Quality Supply Chain program to assess supplier’s risks and identify the necessary verification activities
Provide quality leadership, management and direction to Quality Assurance staff team members
Partner closely across the organization to develop appropriate strategies and objectives that drive continuous improvement in food safety, product quality and regulatory compliance
Take affective action to achieve, maintain and improve product quality, food safety programs and regulatory control programs
Oversee Quality Assurance functions as well as providing leadership to build cross functional processes from concept to commercialization
Provide quality engineering input during the product design, review and approval process
Ensure all inspection and testing, as part of product acceptance performed on behave of B&G Foods, comply with internal control procedures and external quality systems, regulation and standards
Lead risk management activities throughout the product lifecycle, including new product development and post production management
Possess an excellent understanding of FDA, USDA and labelling legislation
Possess complete understanding of FSMA rulings and ensure prompt implementation
Enforce document investigation; such as audits, product complaints, discrepancies in production and processes

Director, Quality Assurance Resume Examples & Samples

Serve as the leader of Cincinnati Quality Operations department and the position is accountable and responsible for the strategic leadership, management and direction of the Cincinnati Quality functions
Engage and develop a best in-class quality team, ensuring that the organizational structure, talent and resources are aligned with key business imperatives and delivers results with a commitment to excellence and a dissatisfaction with the status quo
Assure the development of targeted short and long-term programs to maximize product quality and availability thereof, and to improve demand planning as a basis for competitive advantage
Provides continuous support, training, mentoring, and development to ensure Cincinnati Quality performs at a maximum performance level
The Director, Cincinnati Quality Operations will apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues and enjoy the challenge of managing a team across a matrix organization
The Director, Cincinnati Quality Operations shall create a culture of high-performance and holds self and others accountable and enforces high standards, while demonstrating tact and diplomacy and making difficult or unpopular decisions for the good of the business
The Cincinnati Quality leader would create an environment in which creativity and innovation are the norm and change is not only accepted but encouraged by championing innovation and change
Progressive management experience is strongly preferred
Prior experience with Medical Devices and Instruments is required
Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), MEDDEV 2.12-1, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169
Build high levels of engagement throughout a plant environment
Build a superior leadership team and bench
Develop and maintain key internal and external professional relationships
Generate results, enthusiasm, high levels of trust, commitment, and a sense of urgency
Quickly gain the respect and support of own staff and fellow leaders
Build customer relationships with Integra LifeSciences’ partners in order to facilitate strong forecasting, product launch planning, and execution, and to ensure effective customer problem resolution
Excellent organization and interpersonal skills
Exemplifies Leadership Integrity and Courage
Ability to travel up to 20% of the Time

Director, Quality Assurance Resume Examples & Samples

Key member of Senior Leadership Team that manages, develops and drives Merit Medical Systems Inc. (MMSI), to deliver the goals of the business i.e. Best in Class (Safety, Quality, Business Processes), Revenue Growth & New Business Development
Sets strategy to enhance and maintain MMSI's Quality Assurance Programs, to meet the required regulations applicable to the processes managed, products produced, markets served e.g. US, Canadian, EMEA, Asia, CSR (Customer Specific Requirements)
Assigned Quality System Management Representative for Merit Medical Systems Inc.; primary regulatory agency and customer contact on all quality related queries for the region e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements
Select, provide guidance, direction and supervision to Quality Assurance Personnel. Identify and make provision for required training to ensure proper and efficient completion of all quality assignments. * Develop and manage quality departmental budgets
Promote, support the Business Excellence Program; lead by example; Partner with function leaders to ensure that this program and the organization values are at the forefront of decision making and action
Partner with Global Quality Assurance Team and other Merit Medical sites in the development of partnership systems for standard business, quality processes
Education and/or experience equivalent to a Bachelor's Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher); Post graduate diploma/Masters in Quality Management desirable
At least ten years of work related experience, of which a minimum of four years' experience in a related management role, coupled with a proven track record in leadership and development of a large team. * Proven track record in leading organizations through external inspections / audits (e.g. FDA, Notified Bodies, Competent Authorities, Customers), essential
Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), Canadian Medical Device Regulation (CMDR) and JPAL/JGMP, ISO 13485 Quality System Standard and ISO 14971 Risk Management
PC skills including standard offices packages as well as ability to understand and learn customized computer software programs
Strong Leadership ability, with presence and the ability to influence at all levels within the organization
Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident at all levels, internal and external
Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation

Director Quality Assurance Resume Examples & Samples

Recommend and implement corporate global quality strategy
Interface with customers and lead customer complaints resolution and feedback
Responsible Management Representative in all matters relating to the QMS
Ensure that the quality management system is compliant with all applicable industry, local, national, and international regulatory requirements and standards such as AS9100, ISO 9001, and ISO 13485
Establish product and processes metrics that effectively measure and improve performance
Manage resources based on work level demands and budgetary constraints
Develop and effectively manage operating, staffing, and capital projects budgets
Establish and achieve annual department operating objectives and plans
Leads the supplier quality assurance program and continuous improvement plans through the application of quality tools and techniques
Leads the quality production program to ensure conformity of purchased material and final products to quality standards
Uphold the company's core values of Integrity, Innovation, Accountability, and Teamwork
Demonstrate behavior consistent with the company's Code of Ethics and Conduct
Thorough knowledge and understanding of Quality Assurance processes, procedures and work instructions within the Semiconductor/ Optoelectronics industry
Thorough understanding of AS9100, ISO 9001, and ISO 13485 standards and the AS9100/ISO9001 and ISO 13485 certification process
Bachelor's degree from a recognized institution (Engineering discipline preferred), Master's degree in QA/QC preferred
Minimum of 5 years professional experience in a managerial role or 10 years of working experience in a Semiconductor/ Optoelectronics manufacturing environment or equivalent professional knowledge
Aerospace and Medical Device experience highly preferred
Thorough understanding of AS9100, ISO 9001 certification process
ISO 13485 standards and certification process highly desired
Ability to lift about 25 pounds
Ability to walk throughout the facility
International travel may be required up to 20%
Must be a US Citizen, as required by our contract with the US Government

Director, Quality Assurance Resume Examples & Samples

Plan, schedule, conduct, report and close audit activities in as outlined in the ECD QA strategic plan and on behave of customers as outlined in corporate contracts
Assist in establishment of quality assurance and control policy by providing consultation and recommendations to regional and Global QA Management
Serve as author for QA SOPs and may act as regional QA representative to the global QA SOP taskforce
Serve as QA representative on Global SOP Taskforce(s) for other Quintiles functional areas as assigned
Participate in or lead teams for special projects as assigned. Teams may be cross functional
Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
Host customer audits and participate in review of corrective action plans
Recommend systems for audit, write systems audit plans and coordinate scheduling, conduct, reporting and closure of internal system audits
Serve as QA Contact for QuintilesIMS ECD Operational Management in the Americas region and globally as assigned
Oversee documentation, reporting, and closure of compliance issues
Support QA Management in proposal reviews and reporting QA metrics
Act as primary back-up for QA management
May present trend analysis results and QA metrics to Quintiles upper management
Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters
Excellent problem solving, risk analysis and negotiation skills
Senior Management experience in Quality Assurance
Travel is required and may include some international travel

Director, Quality Assurance Resume Examples & Samples

Promote a customer-focused orientation and an environment of respect, cooperation, participation, and continuous improvement
Actively directs and performs a key role in developing and managing positive Business Partner and vendor relationships. Oversees such relationships in which the QA team participates
Initiate problem avoidance measures and remove barriers to providing quality service
Foster strong partner relationships across sites and across all management levels within the IT organization
Bachelor’s Degree in Information Technology or related field preferred
10+ years IT and QA experience or similar business experience
Previous management experience preferred
Knowledge of and experience managing systems technology, QA practices such as developing test strategies and plans, ensuring quality requirements and design, testing processes, defect tracking and reporting, other IT processes and operations
Strong verbal and written communication skills, with an ability to express complex technical concepts in business terms
A proven track record in leading and managing major technology projects. Solid organization, planning and execution skills for projects, from vision through implementation, including solid project budget management skills
Able to identify, develop and implement new ideas through collaboration with stakeholders
Able to meet objectives, demonstrate initiative and develop new skills
Possesses solid relationship management skills with multiple audiences (staff, vendor, other IT organizations, business partners, company management)
Understands various computer environments
Strong analytical, problem-solving, and conceptual skills
Proficient with testing tools
Knowledge of Security and compliance policies and procedures and their applicability to areas of responsibility and vendor management
Proficient and strong understanding of project development life cycle and software development life cycle

Director Quality Assurance Engineering Resume Examples & Samples

Supervise direct reports to ensure quality testing of products being developed
Must ensure the communication on the status of projects in test, manage expectations of deliverables, and work with other departments to get their input and notify them of our timelines and needs
Direct the planning of testing efforts, including scoping the needed tools, and creating test timelines and schedules
Review Test & Bug Reports for thoroughness and accuracy
Able to work and communicate well with others
Ability to use Office tools to prepare persuasive and informative reports is required along with a strong understanding of metrics, trends, and reporting
Ability to provide clear instruction and direction
15+ years of testing experience
A degree in Computer Science or related technical field preferred (BSCS, BSCIS, BSMIS, BSIS&T)
Proven success using professional software testing and quality assurance practices resulting in quality products and smooth timely delivery
Excellent understanding and hands on experience implementing automated regression testing tools to shorten release times

Director, Quality Assurance & Compliance Resume Examples & Samples

Team with Site Compliance Directors in areas of compliance to proactively identify initiatives and quality system enhancements. Identify areas of continuous improvement for simple lean Quality system deployment (MPS) and ensures best practice sharing and drive improvement across sites. Champion various compliance initiatives according to Operating Unit and MMD priorities, as directed
Maintain, communicate and evaluate the performance metrics of key Quality Systems and Quality Assurance programs across sites as per the drivers of KPIs as identified by Operating Unit/MMD, including but not limited to
At least ten (10) years of work experience in a pharmaceutical and/or vaccine manufacturing environment or strongly related, similarly regulated field
Strong understanding of cGMPs across multiple global regulatory agencies
Strong compliance mindset
Strong lean mindset with prior MPS/Kata capabilities is a plus

Director, Quality Assurance Resume Examples & Samples

Direct, coach, develop and mentor the team to accelerate a culture of high performance
Direct the team to ensure all requirements of the Product Development Process (PDP) are met, including product/process, regulatory, and Quality System compliance. Additionally, provide guidance and coaching for post market product sustaining activities, such as design changes, complaints and CAPA. The position may also provide support for OEM quality functions, assist in complaint investigations and participate in due diligence activities
Review, analyze and report on quality discrepancies related to assembly, process and product function systems and develop disposition and corrective actions for recurring discrepancies
Interface with manufacturing, engineering, customer, vendor and subcontractor representatives to determine responsibilities and solutions. May serve as liaison between the company and the various governmental agencies
Work directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications
Focus on product quality and continuous improvement with customer and patient care as the single most critical priority
Ensure all training requirements are met for the staff to fulfill his/her position
Assume leadership role for group or business decision making and assume role of auditee SME and audit participant. As part of senior management role and Business Unit staff, represent QA function in all aspects of running and managing a business for the Business Unit. This includes but is not limited to project investment boards, product portfolio sessions, quarterly Business Unit meetings, senior staff meetings, management reviews and board level meetings
Facilitate Management Reviews, Complaint Investigations, post market compliance requirements and oversee BU compliance activities. Participate in product adverse events such as product recalls
Work closely with various Business Unit functions and other quality functions in ensuring that all aspects of product development, product sustaining, and externally supplied product and post market activities are conducted in a manner that it meet BSC and regulatory requirements
Participate and/or lead and/or guide due diligence efforts for acquisitions, integrations, new business alliances and maintain staff that can provide effective partnership in meeting BU needs with new technology groups
Work very closely with various manufacturing plants in ensuring product development, manufacturing, commercialization and sustaining meets BSC and QSR standards. Provide BSC sites with complete design sustaining support and as needed support with various corporate initiatives

Director Quality Assurance Handheld Diagnostics Resume Examples & Samples

Bachelor/Master degree with at least 9 years relevant experience in Quality functions
Background in a Regulated Industry (IVD, Medical Devices) is required
Experience with design controls in an R&D environment is required
Background in IVD medical devices is a strong preference
Practical knowledge of medical European and US standards and regulations is a strong preference
3+ years of people management of a larger team of at least 8 to 10 people; direct and indirect (required)
Excellent verbal and written communication skills (English)

Director, Quality Assurance Operations Resume Examples & Samples

Lead QA personnel supporting manufacturing operations in 5+ Medical Device manufacturing sites throughout Latin America
Budgeting, planning and resource evaluation
Meet with production management on regular basis and support goals outlined in the company’s operating plan
Develop strategies to implement Quality system regulations and continuously improve Quality processes
Interface with internal constituents and external regulatory bodies regarding compliance needs
Define, communicate and enforce quality policies with particular emphasis on compliance to the company’s Quality System and external regulatory standards
Bachelors and Advanced degree in related field, or equivalent work experience, preferred
15+ years minimum of Medical Device manufacturing experience in functions such as QA, RA, Compliance, Operations, OpEx, Manufacturing, Supply Chain
5+ years of experience working in and managing employees in Mexico, Costa Rica or other LATAM countries
Experience managing external Regulatory Agency compliance audits (FDA, ISO, etc)
Strong product manufacturing technical background as well as knowledge of Medical Device Quality System regulations
Experience in product manufacturing transfers, facility/line startup, etc
Bilingual fluency in English and Spanish required
Provides leadership to managers and experienced professional staff may also manage front line supervisors
Manages an organizational budget
Assists in the development of functional strategy
Decisions have an extended impact on work processes, outcomes, and customers

Director Quality Assurance & Compliance Resume Examples & Samples

Maintain Company Regulatory (FAA PMA, FAA FSDO, CAAC, and EASA) approvals
Maintain Company AS9100 and ISO 9100 Approvals
Manage and implement the internal audit program, and host second and third party audits
Manage and implement the Corrective Action & Preventive Action Process
Maintain the Record Management processes, overview and manage the outside record retention storage, record scanning and hosting processes, record retrieval process, and suppliers record service support
Provide Sales & Marketing with quality & regulatory compliance related proposals inputs and quality compliance matrix
Provide Customer Administration & Contracts with feedback regarding customer imposed PO quality provisions, and address and resolve customer / PO Regulatory PMA issues
Perform contract review for quality provisions as part of the contract formation process
Review and support updates to Quality Management System (QMS) processes, Quality Policy and Procedure Manual (QPPM), Design Quality Assurance Manual (DQAM), and FAA Supplemental Manuals for compliance with internal, customer imposed AS/ISO and regulatory requirements
Review and support manufacturing quality process changes for compliance with imposed requirements (AS/ISO, Regulatory, and customer)
Review and support the development processes and provide guidance for compliance with internal and customer imposed requirements
Review and approve Teledyne Process Specifications (TPS), and support TPS process changes for compliance
Define and capture Customer, Program, and Regulatory Quality requirements to be imposed on Suppliers and on specific new development programs/products
For new development projects, review new or updates to Supplier related Statement of Works (SOWs) to ensure that they include appropriate quality provisions and quality requirements
Directly supervises subordinate managers and supervisors. This position is responsible for the performance management and hiring of the employees under direct supervision
Must be a US Person due to iTAR restrictions
Bachelor's degree (B.A.) from a four-year College or University required
A minimum of 10 years’ of Quality Assurance experience in an Aerospace, Avionics or Aviation environment
A minimum of 5 years' experience in a Supervisory/Managerial role
Experience in Quality Compliance
AS9100/ISO Audit experience; Certified Auditor preferred
Experience in an FAA Part 21 and Part 145 working environment and/or training
Experience performing Quality Assurance of Black Boxes in an Aerospace environment
Recent IPC-610, IPC-620, IPC-600, and J-STD-001 strongly preferred
Proficient in Microsoft application tools: Outlook, Windows, Word, Excel, Access, SharePoint, Project, Visio
Must be able to read, write and speak English (FAA requirement)
OEM Processes such as Airbus GRESS & ABD0100 working knowledge is preferred
DO-178 & DO-254 product life cycle processes knowledge is preferred
ASQ Certificate in Quality Leadership, Quality Audit, Quality Engineering or Six Sigma is preferred

Director, Quality Assurance GxP Compliance Resume Examples & Samples

Develop Avanir Internal Audit Program and overall process including reviewing, improving, and updating current GxP Audit SOP’s. Conduct Avanir Internal Audit every year for each of the critical GxP functions, processes, and systems
Work closely with Clinical, CMC, and Internal Department Heads to plan for the annual audit; ensure that audit plan is fully and effectively executed
Work with Contract/Consultants and Otsuka Quality Team to facilitate and conduct GxP Audits
Perform for Cause GxP Audits, and Perform Inspection Readiness Mock Audits
Be part of the Inspection Readiness Team to help with managing all global on site regulatory inspections
Develop Annual global GxP Audit plan. In addition, as part of the GxP Audit Team, perform Quality audits of global clinical investigator sites, clinical vendors, data management, and internal clinical systems/operations, Contract Manufacturers, Contract Laboratories
Document and report quality /compliance issues relating to the commercial and clinical processes and products
Manage post-audit activities and follow-up on any necessary corrective and preventive actions
Gather and interpret regulatory intelligence, as well as evaluate internal practices, make recommendations for improvement and execute against action plans
Interpret policies, standards and regulations and evaluate potentially critical problems not covered by policies, standards and regulations
Exercise judgment in ensuring that written procedures are followed
Evaluate quality systems, processes, procedures and protocols for compliance
Develop internal SOPs, policies and procedures as required
Where required, draft quality agreements with Clinical Vendors
Track, trend GxP Audit KPI Metrics
Will manage at least one Quality Compliance Staff
Escalate regulatory compliance risks to Quality Leadership to ensure that all issues are mitigated in a timely manner
15+ years of experience in pharmaceutical industry
10+ years of experience in GxP auditing (GCP, GLP, and GCP) Auditing experience
Working knowledge of GxPs and quality systems
Must be able to effectively collaborate with others and work in a matrixed team
Must be flexible, resourceful, and multitask efficiently
Great Leadership Qualities. Lead by example as he/she represent Avanir to contract vendors during audits
Excellent project management skills are a must

Director, Quality Assurance Operations Resume Examples & Samples

Role will lead QA Operations in 4+ Medical Device manufacturing sites throughout US and Mexico
Interact with external customers and internal stakeholders on quality related topics
Spanish fluency preferred
Able to travel up to 25%
10+ years minimum of Medical Device manufacturing experience in functions such as QA, RA, Compliance, Operations, Operational Excellence, Manufacturing, Supply Chain
5+ years of experience managing employees
Strong interpersonal skills and experience interacting directly with customers

Director, Quality Assurance Resume Examples & Samples

Driving continual improvements to the efficiency and flexibility of current software development practices
Coordinating the establishment and execution of quality processes and strategies
Building a QA roadmap for tools/frameworks to further speed up the development/QA processes
Providing technical leadership to both dev and QA teams
Engaging with remote teams as well as stake holders to track delivery of major initiatives
BS Computer Science or equivalent
Designing and developing test automation framework
5+ years experience as an SDE or SDE-T
1+ years experience as a People Manager
Knowledge of modern programming languages, OO and Service Oriented Architecture
Experience designing and developing large scale, high traffic applications
Experience managing projects and teams in an Agile environment

Director Quality Assurance Resume Examples & Samples

Manage a group of quality assurance professionals responsible for support of our contract manufacturing and laboratory sites
Proactive improvement of local quality management systems related to management of external contracted services
Partner with organizations within the commercialization process to effectively execute process and testing transfers
Represent quality organization in related Network teams and company-wide initiatives
Participate in regulatory inspections and site audits
Management of departmental budget
Doctorate degree and 4 years of Quality experience OR
Master’s degree and 8 years of Quality years OR
Bachelor’s degree and 10 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Bachelor’s Degree in a Science field
15 + years’ pharmaceutical industry experience
Strong experience working in a GMP environment
Able to facilitate and influence clients and partners
Familiarity with basic project management tools and lean
Strong experience in a manufacturing and/or quality assurance environment
Ability to interpret regulations

Director, Quality Assurance Resume Examples & Samples

Manages and coordinates quality improvement (QI) programs are developed and managed using a data driven focus that sets priorities for improvements aligned to ongoing strategic direction
Develop, monitor/track, and evaluate all process performance measures, identify data trends and make recommendations for new quality improvement initiatives when appropriate while working with the Employee Services leadership team to create policies and procedures that ensure quality
Prepares and process quality reports by collecting, analyzing, and summarizing information and trends including KPI’s and SLA management
Track Employee Services metrics and create monthly consolidated scorecards
Lead a team that will manage day-to-day on project-related activities. Ensures team produces, drives and manages project schedules status, resources, deliverables and timelines throughout the project with input and feedback from the business team
Manages team that will calibrates call center performance on a daily, weekly, and monthly basis
Manage random quality audits for various intake channels (i.e. Calls, Chats, etc.)
Partner with CI team on process redesign efforts associated with the implementation of new Employee Services technologies and ongoing maintenance
Detail-oriented review of weekly Service Level Agreement (SLA) metrics to identify trends with SLA’s and identify , what corrective actions need to be taken to improve going forward
Designs and manages quality assessment and improvement projects: identifies, assesses and manages metrics and processes
Bachelor's degree (B.A.) from a four-year college or university required. 2-3 years customer service, training, quality assurance, management or equivalent combination of education and experience
Six Sigma/Lean Certification preferred
8-10 years combined experience devising and executing on continuous improvement strategies
Experience with project management, technology implementations, multi-tasking and stakeholder management
Resourceful; quick learner; experience working in a fast paced, changing environment
Ability to “connect the dots” across businesses
Subject Matter Expertise – Deep knowledge and experience in process improvement, evaluating success, and HR operations
Customer Service – Innovative mindset and awareness of service excellence in order to propose new and creative solutions for continuous improvement
Trusted advisor – Ability to influence change and build relationships with internal HR stakeholders and external vendors
Prioritization - Ability to prioritize problems in terms of strategic and possible impacts
Strategic Business Planning - Ability to perform strategic business planning by proactively applying continuous improvement skills to identify and act on new opportunities

Director, Quality Assurance Resume Examples & Samples

Evaluate existing quality assurance system and develop a roadmap to execute the vision and strategy to achieve operational excellence
Establish and embed a quality culture mindset throughout the organization and ensure strong and effective relationships with value stream management, supply chain, and engineering
Ensure that relevant quality policies, practices and procedures are developed, maintained and adhered to
Develop, implement, and monitor key performance indicators/quality metrics that drive quality improvement and reinforce the desired quality culture
Partner with compliance team to ensure adherence to all government regulations, state requirements, and Trinity requirements
Recommend permanent corrective actions or policies that result in cost of poor quality reduction
Develop and implement defined quality best practices across the business
Ensure that all inspection and testing comply with the quality procedures and work instructions
Provide quality leadership, management and direction to the manufacturing plant quality staff and team members
Travel 40 – 50%
Bachelor’s degree in Quality, Operations, Manufacturing Engineering or other related field
Minimum of 15 years of senior quality assurance and systems leadership embedding a quality mindset in the culture
Experience with ASME Section VIII Division 1 and 2 codes preferred
Proven leadership skills with strong business acumen and personal effectiveness/credibility
Excellent management and problem solving skills; able to lead, direct, empower, support and encourage the development of team members
Expertise in quality systems and knowledge of ASME/DOT regulations

Director, Quality Assurance Resume Examples & Samples

12+ years of quality assurance experience, preferably in a call center environment
Proven leadership experience managing large global teams
BA/BS degree in Communications or equivalent work experience required
Possess contract negotiating capabilities to help build potential partnerships; needs to be able to bring staff and key influencers together to work in concert
Experience in a customer service environment or related position, preferably in a teleservices or telecommunications company

Director, Quality Assurance Resume Examples & Samples

Direct all phases of highly technical quality assurance audit activities
Oversee the preparation, documentation and conduction of Quality Assurance audits of Distribution Centers, joint Ventures, X-Ray Centers, private label manufacturers, non-manufacturing suppliers of Medical Devices and Pharmaceuticals
Direct and oversee Quality Assurance audits to ensure the effective and timely facilitation of suppliers and internal quality audits and follows-up on CAPAs/Observations
Oversee suppliers to assure the quality of their products, materials, components and/or operations
Lead in the monitoring of supplier performance efforts and recommend changes to improve the production process
Stay current with new or potential business opportunities, and prepare for all QA activities
Direct and oversee the research for applicable FDA, ISO and ASTM standards to ensure the company’s ongoing compliance with U.S. and International Regulatory Requirements (Medical Devices Directives and FDA QS requirements)
Assist with due diligence and follow-up surveillance audits as required and serve as SME for some manufacturing partners
Assess the effectiveness of existing policies, guidelines and procedures and recommend changes
Provide ongoing direction and guidance to the team and provide guidance and development opportunities as needed
Select, develop, and evaluate TSMs to ensure the efficient operation of the department
Attract, retain, motivate, coach and develop team members for high performance
Understand, interpret and act on financial information that contributes to business profitability
Ability to plan and manage complex projects, manage risks, costs, time and project teams
Excellent planning/ organizational skills and techniques
Communicate effectively with senior management and key stakeholders
Uses skills to lead teams to achieve company goals in effective ways
Ability to Influence, build relationships, navigate politics and manage conflicts
Broad and wide-range of professional and managerial skills with a full understanding of industry practices and company policies and procedures
Ability to lead and develop virtual teams
Strategic planning skills

Director Quality Assurance Resume Examples & Samples

Implements and manages quality activities throughout the facility including peer review, quality initiatives and other PI activities
Responsible for data analysis, collection and outcomes measures
Manages processing and completeness of medical staff and allied health professional applications for appointment, reappointment, or privileges in accordance with Medical Staff Bylaws, Rules, and Regulations, and policies and procedures
Ensures and maintains compliance with all medical staff and allied health professional requirements and operations
Manages departmental operations
Maintains compliance with current regulation/requirements of outside regulatory/accrediting agencies and assures that new requirements are identified on a timely basis and coordinates hospital compliance

Executive Director Quality Assurance Resume Examples & Samples

Ensure compliance to quality policies and procedures, install, maintain and improve quality systems, identify and implement continuous improvement opportunities, oversee site, laboratory and micro audits, ensure root cause investigations are completed and preventive action plans implemented in a timely and thorough manner, assure all materials, manufactured and received, meet specifications and are fit for purpose
Ensure compliance to quality regulations as they apply to the Canada site and products supplied from the Canada site to global markets. Ensure compliance of products distributed in Canada from global sources. Maintain an up to date knowledge and understanding of regulatory requirements and compliance
Provide Quality leadership to the Canada site. Oversee the employee training program for Quality to ensure employees are trained to meet Quality expectations for their role. Ensure high touch competencies and talent development processes are established for all QA employees. Lead the measurement and improvement of activities having an impact on product and package quality
Lead the understanding and implementation of the EL, Global Supply Chain and QA Strategies to all Canada site QA employees, to assure that employees understand their role and impact to the strategies. Actively build a collaborative relationship with GBSC, Supply Planning, Receiving, Distribution, Operations, Packaging Development, Consumer Relations, Marketing and Product Development, as they relate to Canada site activities
Lead the investigation of quality issues to a timely and complete resolution. Engage the relevant organizations for products supplied from the Canada site
Manage the QA budget and staffing requirements. Review the monthly department spending to assure budget requirements are met. Actively benchmarks with both internal and external organizations to further expand knowledge/skills and identify improvement opportunities for the organization
Assure that Canadian 3rd party facilities comply with Estee Lauder Quality standards and Canadian drug GMP regulations
10-15 years’ experience in QA Management or a related field
Six Sigma and/or professional certification preferred

Director, Quality Assurance Resume Examples & Samples

12 years progressive experience in IT, including quality assurance required
3 years+ experience managing a team of IT professionals, preferably in quality assurance required
Experience in the development, testing, and delivery of foodservice industry IT solutions preferred
Knowledge of ITIL or related release management and QA processes is required

IT Director, Quality Assurance Resume Examples & Samples

Bachelors or Master’s degree in Computer Science or equivalent experience
Requires 10 or more years of related experience and at least five years of management responsibility
Extensive knowledge of the QA field with advanced leadership skills
Demonstrated ability to effectively supervise, motivate and direct technical personnel
Extensive experience in various SDLC (Software Development Life Cycle) methodologies such as waterfall, agile, etc
Previous experience with requirements and analysis best practices
Experience with both business and technical requirements, including the knowledge of when and how each is needed and applied
Excellent written, verbal communication skills and Excellent negotiation skills
Systems or software development experience, Experience leading several large, complex systems or projects
Superior capabilities for partnering with key customers and colleagues; ability to be effective as both a team member and as a leader of teams
CMST (Certified Manager of Software Testing) or CMSQ (Certified Manager of Software Quality) Certification
Knowledge of Operations and system platforms
Sound judgment; able to balance idealized vision with practical implications. Positive attitude and sense of humor
Strategic thinking and planning; capable of building a roadmap for achieving strategic business goals
Working knowledge of strategic analysis frameworks such as SWOT, value chain, growth-share matrix, etc
Detail-oriented with proven ability to identify creative solutions to complex business problems
Confidence to challenge conventional thinking with fresh and creative insights; ability to independently manage ambiguity and thrive on change
Background in Clinical or Healthcare field

Senior Director Quality Assurance Support Systems Resume Examples & Samples

Oversight of Customer and Consumer Complaints Departments. Ensure complaints are handled in a timely manner, provide oversight for program coordinators, contracted call center, trending of data and reporting
Standardized Compliance Procedures- Ensure consistency throughout DFA and coordination and implementation of new procedures. Work with Training Coordinators to ensure education and competency of all programs/procedures
Vendor & Specification Program-Oversight of activities of Vendor Programs to ensure that DFA has current databases for all ingredients, packaging and finished product specifications, contract services, co-manufacturers, outside warehouses and other vendors. Oversight of Vendor Quality Expectations programs, co-manufacturer auditing and quality expectations and customer request for information for all facilities
Oversight of all QA IT Systems- LIMS Administration and project management, Quality Management Solution software and programs. Lead project teams for implementation of growth and strategic plans

Senior Director Quality Assurance Resume Examples & Samples

Lead the strategic development, implementation, application, and continuous improvement of Genomic Health’s Quality System meeting both operational quality and regulatory requirements for our global business, with an initial focus on the US, EU, Canada, and Japan
Lead Genomic Health’s Corporate Quality Assurance function, with direct management responsibility for the staff and accountability for ensuring that this team has the technical and professional skills, organizational structure, capacity, and business processes in place to maximize the value of Genomic Health’s Quality System
Facilitate effective cross-functional communication, alignment, collaboration, leadership and execution on quality-related objectives, plans, and priorities
Keep abreast of the evolving regulatory policy and industry best practices related to Laboratory Developed Tests and In Vitro Diagnostics in the US and internationally, leading the evolution of our Quality System as appropriate to adapt to these
Develop business cases for proposed investments and changes in systems, processes, staffing, and organizational development for Quality Assurance, providing clarity on costs, benefits, alternatives, resource requirements, and other relevant information to enable timely, effective decision making
Provide expert advice to executives and functional area managers on QA related issues, including those with company-wide or external impact
Collaborate with functional areas to establish and update metrics that are reported to upper management that highlights risks and key opportunities for continuous quality improvement
Provide QA input to manufacturing, Quality Control, and product development processes to maintain compliance with the relevant quality regulations and international standards
Provide QA input and resources to author, review and finalize quality-related documents for regulatory submissions globally, including PMA, 510(k), and CE-IVD
Host FDA/third party regulatory audits (including pre-approval inspections for PMAs), and ensure follow up on findings/observations issued including issuing CAPAs as needed
Serve as Genomic Health’s Quality Management Representative to FDA, other regulatory bodies, and ISO auditors
Lead Quality System Management Review meetings, in accordance with regulations and internal procedures
Identify and suggest functional improvements to the Document Control and Quality Assurance organizations to further ensure regulatory compliance and constant inspection readiness
Ensure Quality representation on Product Development Design teams
Ensure that budgets, schedules, and department performance requirements are met
Bachelors degree in chemistry, biology, engineering or related field
Minimum 8 years of experience in a QA leadership and management role (e.g. Director, Senior Director) in medical device / IVD field, with direct management responsibility for QA personnel and responsibility for a broad spectrum of Quality System elements
Demonstrated success leading cross-functional development, implementation, application, and maintenance of Quality Systems which comply with FDA QSR, GCP, GLP, and related US and international regulations and ISO standards pertaining to IVD development and ongoing commercial manufacturing and delivery Successful track record of selecting, implementing, and optimizing electronic quality management system software including modules for document control, complaints, nonconformances, CAPA, and other Quality System functions
Successful track record leading FDA and ISO inspections and internal quality audits
Exceptionally strong team leader and team player with excellent interpersonal and communication skills, and experience working with end-users in a coaching capacity
Extremely detail-oriented with strong organizational skills and high quality standards
Outstanding written communication skills with experience in authoring both internal and externally facing quality related documents
Superb interpersonal and verbal communication skills, with the ability to effectively communicate with employees, functional area and executive management, customers, and business partners
Self-motivated, hands-on critical thinker and problem solver, with the ability to lead by example, an enthusiastic, optimistic outlook, and a collaborative style
Ability to integrate and apply feedback in a professional manner
Experience with molecular diagnostic assays is strongly preferred
Working knowledge and experience with Clinical Laboratories, Laboratory Developed Tests, and the relevant regulatory requirements and quality standards (e.g. CLIA, CAP, NY, EU IVDD, and ISO 15189) is highly desirable
Previous experience in other functional areas (R&D, Quality Control, Operations), in addition to QA experience is a plus

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Director, Quality Assurance Resume Examples & Samples

Director, Quality Assurance Resume Examples & Samples

Director, Quality Assurance Resume Examples & Samples

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Director, Quality Assurance Resume Examples & Samples

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Director, Quality Assurance Resume Examples & Samples

Director Quality Assurance Resume Examples & Samples

Director Quality Assurance Resume Examples & Samples

Director, Quality Assurance Resume Examples & Samples

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