DePuy Synthes Companies is a member of Johnson & Johnson's Family of Companies, and is recruiting for a Supplier Quality Engineer I located in Raynham, MA.
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.
• Assist 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 audits to good manufacturing practices, international organization for standardization and any other applicable standards.
• Provide 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.
• A minimum of a Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred.
• A minimum of 1 year 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.
• Both, FDA and ISO regulations knowledge is preferred; FDA CFR Part 820 and/or ISO 13485 knowledge is highly preferred.
• Auditing background is preferred.
• 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 require up to 25% travel, including possible international travel.