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Quality Assurance Manager

Company: Becton Dickinson
Location: Woburn
Posted on: June 25, 2022

Job Description:

Responsibilities Job Description Summary Job Description Be part of something bigger BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. Summary of Position with General Responsibilities: This position will serve as the Quality Engineering Manager for the Woburn Manufacturing facility. The primary responsibilities center on resolving manufacturing issues by implementing effective solutions, revising facility documentation for accuracy and compliance, validating equipment/processes/product as needed, and identifying/implementing continuous improvement projects. Essential Job Functions: Manages QE department and overall expectations pertaining to setting accurate schedules, costs and resources. Ensures department is adequately resourced and trained to perform jobs effectively. Directly supervise QE staff including coaching and developing to enable maximum performance and individual employee growth, providing regular performance review and feedback and using corrective action as necessary. Maintain company compliance of FDA Quality System Regulations and ISO:13485 standards. Identify and resolve issues in the manufacturing of Class III PMA medical device products, by designing and conducting Quality Engineering investigations, and working directly with manufacturing engineering, operators, and other plant personnel. Oversee the Material Review Board (MRB), which includes providing leadership and coordination of activities for the investigation and disposition of non-conforming product and/or components. Conducts design-related failure and hazard analysis for manufacturing support and Supplier process improvements. Review and approve validations (IQ/OQ/PQ) and qualification studies as needed for new/existing equipment (inspection & process), software, components, etc. Manage CAPAs and Audit Action Plans to completion using risk analysis, project management, and proper effectiveness verification methods. Revise procedures as needed based on nonconforming material investigations, CAPA, complaints, continuous improvement projects (CIP), and compliance to local, division, and corporate procedures, in addition to local and international quality regulations. Represent the Quality function on committees, teams, task forces as assigned. Basic Qualifications: B.S Degree in Engineering required or bachelor's degree in technical area, Master's Degree preferred. Minimum 5 years within medical device industry, preferably in Class II/III manufacturing environment. High level of competence in Quality Technology including statistical techniques, control charts, sampling plans, process capability, process/equipment validation, Gage R&R, design of experiments, correlation and regression, analysis of variance, probability, etc. Strong statistical software and MS Project skills. Strong oral and written communication skills. Ability to motivate people and mentor engineers. Understanding of ISO 13485, MDD/MDR, GMP, QSR, and other applicable regulations, and the ability to interpret these as they apply to company issues. Strong project planning skills focused on meeting customer needs. Proven leadership skills in a fast-paced environment. Working knowledge of GMP and FDA regulatory requirements for Class III medical devices or equivalent Experience in medical device Class II/III environment preferred. Ability to multi-task effectively. ASQ Certified Quality Engineer and/or Six Sigma Black Belt preferred. ASQ Certified Quality Auditor or equivalent preferred. Key Relationships Internal Relationships: Quality Systems Quality Managers/directors Production Supervisors & Managers Manufacturing Engineers Purchasing External Relationships: Functional and corporate management Other Business Units Regulatory Agencies and Notified Bodies Industry peers and associations. Physical Demands: Mostly office work. Must be able to wear a respirator, if required. Must be able to enter into clean rooms, if required. Work Environment: Quality Control, Micro and Chem Laboratories, Incoming and Product Released, Manufacturing Areas, Quality Systems. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why join us? A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components - is designed to support the varying needs of our diverse and global associates. To learn more about BD visit Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. PDN LI-PRO Primary Work LocationUSA MA - Woburn Additional Locations Work Shift Apply Save Job PDN-968142ab-bfbe-4dcc-89f9-70da5048fcf9

Keywords: Becton Dickinson, Boston , Quality Assurance Manager, Executive , Woburn, Massachusetts

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