DePuy Synthes Companies is a member of Johnson & Johnson's Family of Companies, and is recruiting for a Supplier Quality Engineering Team Leader 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.
• 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 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.
• The Team Leader Supplier Quality will 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 focus. The Team Leader Supplier Quality will have leadership responsibilities within the group and will help manage and direct the work of other Quality Engineers.
• A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline.
• A minimum of 5+ years of experience in a highly regulated industry is required. Supervisory experience preferred.
• Experience in the Medical Device industry is preferred. Experience in the Pharmaceutical industry is an asset.
• FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge preferred.
• Auditing background is an asset.
• Strong communication, teamwork, and problem solving skills.
• Strong in root cause analysis skills required.
• Experience or knowledge with machining manufacturing processes and injection molding an asset.
• Six Sigma, Lean, or ASQ Certification and trainings an asset.
• The ability to direct a team in meeting departmental goals and objectives, make effective oral and written presentations, to prioritize and manage multiple projects consisting of varying degrees of complexity and to analyze complex problems and apply practical solutions will be needed.
• This position will require up to 25% travel.