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|Manager, Design Quality Engineering|
Company: Cardinal Health
Location: Mansfield, MA
Employment Type: Full Time
Date Posted: 05/12/2021
Expire Date: 07/18/2021
Job Categories: Accounting/Auditing, Engineering, Healthcare, Practitioner and Technician, Insurance, Manufacturing and Production, Executive Management, Quality Control, Research & Development, Medical, Writing/Authoring
Manager, Design Quality Engineering|
Manager, Design Quality Engineering
Reports to: Director Design Quality Engineering
The Manager, Design Quality Engineering is responsible for leading and managing quality assurance of medical device products and processes. This position will manage quality and compliance activities for Cardinal Health which includes diverse medical devices including Electromechanical devices. The QA team led by this position ensures that product quality and regulatory compliance goals are met for new product development project and released products.
Provide leadership, oversight and training to Quality and R&D engineers on design controls, risk management, verification and validation practices, and statistical methods. In collaboration with cross-functional team members, shall also provide leadership oversight for the satisfactory resolution of any quality or compliance issues related to released products that are currently on the market.
Lead Design Quality Engineers who provide quality support in design, development and changes to medical device products. Drive successful execution of quality and compliance strategy and annual Quality Goals. Partner with R&D and center-led Quality Operations team to drive excellence in product quality and regulatory compliance. In collaboration with R&D and manufacturing quality, establish design transfer guidelines. Represent the Quality function on cross-functional governance boardssuch as Corrective Action Board, Design Stage Review Board, Management Reviews etc. Coordinate or lead design quality related product complaints investigations. Set Quality teams annual operating goals and objectives. Coach and develop for team members and manage teams performance. Manage department resource allocation across multiple product lines. Provide training/guidance on design control, risk management,statistical methods, industry related standards, and regulatory expectations. Author design control and risk management procedures. Interact with FDA or Notified Body inspectors during audits.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Support corporate continuous improvement initiatives. Project Management, special projects and initiatives. Other duties as assigned with or without accommodation.
Anticipated Pay Range: $90,000 - $149,00
Bonus Eligible: Yes
Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD, etc
Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.