Johnson & Johnson Careers
Supplier Quality Engineer III
Palm Beach Gardens, Florida
Requisition ID: 2255180524
DePuy Synthes Companies of Johnson & Johnson is seeking a Supplier Quality Engineer III to join their team in Palm Beach Gardens, FL.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic 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 patient care in greater ways than either company could accomplish on its own.
As the Supplier Quality Engineer III, you will provide 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.
Major Responsibilities & Duties:
- 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.
- 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.
- Additional duties as assigned.
- A minimum of a Bachelor's Degree is required; a degree in Engineering, Life Science, or related discipline is preferred.
- A minimum of 5 years of quality engineering or related 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.
- Both, FDA and ISO regulations knowledge is required; FDA CFR Part 820 and/or ISO 13485 knowledge is preferred.
- Auditing background is preferred.
- Strong communication, teamwork, and analytical skills are required.
- Strong root cause analysis skills are required.
- Experience and/or knowledge with machining manufacturing processes and injection molding is preferred.
- Six Sigma, Lean, or ASQ Certification and trainings are preferred.
- This position will be based in Palm Beach Gardens, FL and will require up to 15% travel.
Do you strive to join an outstanding team that is dynamic and constantly growing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Florida-Palm Beach Gardens
Depuy Orthopaedics. Inc. (6029)