Johnson & Johnson Careers
Senior Supplier Quality Engineer
Requisition ID: 1460180906
DePuy Synthes is currently recruiting for a Senior Supplier Quality Engineer located in Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great 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 innovative, comprehensive solutions, we are inspired to advance
You, the Senior Supplier Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of Johnson and Johnson products.
Responsibilities are defined below:
- Conduct audits 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. You will utilize multifaceted industry and process excellence standards on an expert 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.
- Oversee audits 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.
- Handle complex technical issues for manufacturing processes that are to be transferred to satellite facilities. Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management. FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.
- A minimum of a bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred.
- A minimum of 4 years of experience in a GMP and/or ISO regulated industry is required. Experience in the medical device and/or pharmaceutical industry is preferred.
- Operations supplier quality experience is preferred. FDA CFR Part 820 and/or ISO 13485 knowledge is preferred. Auditing background is preferred.
- Strong communication, teamwork, and problem-solving skills are required.
- Strong root cause analysis skills are required.
- Experience or knowledge with machining manufacturing processes and injection molding is preferred. Six Sigma, Lean, or ASQ Certification and/or trainings are preferred.
- This position will be based in Raynham, MA and will require 25% travel, including possible international travel.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
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.
Depuy Orthopaedics. Inc. (6029)