Johnson & Johnson Careers

Supplier Quality Engineering Team Leader (1 of 2 Openings)

Raynham, Massachusetts
Quality (Eng)


Job Description

Requisition ID: 6186190201

DePuy Synthes Companies is a member of Johnson & Johnson's Family of Companies, and is recruiting for a Supplier Quality Engineering Team Leader.

DePuy Synthes Companies of Johnson & Johnson is the largest, most creative and comprehensive orthopedic business in the world. These companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two excellent companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop creative, comprehensive solutions, we are encouraged to advance patient care in greater ways than either company could accomplish on its own.

Responsibilities: 

• Provides quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of Johnson and Johnson products.
• Conduct supplier visits to good manufacturing practices, international organization for standardization and any other applicable standards.
• Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
• Utilize multifaceted industry and process excellence standards on an experienced level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
• Address and correct product and process complaints.
• Report on contract manufacturer performance metrics and management reviews.
• Lead supplier visits of all quality system categories to assess compliance to process excellence standards.
• Ensure comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management.
• Evaluating and implementing improved manufacturing engineering performance management and tracking methods, as well as facilitating resolution of complex technical and operational problems.
• Leading and documenting internal supplier quality procedure change efforts. The individual will adhere/comply with and utilize multifaceted industry and process quality standards on an experienced level, including good manufacturing practices (GMP), equipment engineering system (EES), international organization for standardization (ISO) and country/governmental regulations. FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.
• Responsible for technical leadership of supplier process changes in partnership with Supplier Quality
• Partner with NPD team to support successful launches at suppliers.

Qualifications
• A minimum of a bachelor’s degree is required, preferably in an Engineering, Life Science, or related discipline.
• Experience in the Pharmaceutical and or Medical Device industry is preferred
• FDA CFR Part 820 and ISO 13485 knowledge preferred.
• Auditing background is an asset.
• Strong communication, partnership, and analytical skills.
• Strong in root cause analysis skills.
• Experience or knowledge with machining manufacturing processes and injection molding an asset.
• Six Sigma, Lean, or ASQ Certification and training an asset. 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-Massachusetts-Raynham-
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality (Eng)
Requisition ID
6186190201