DePuy Synthes Companies of Johnson & Johnson is seeking a Supplier Quality Engineer III, 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 overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson and Johnson products.
• Conducts 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.
• Utilizes 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).
• Addresses and corrects product and process complaints.
• Reports on contract manufacturer performance metrics and management reviews.
• Oversees audits of all quality system categories to assess compliance to process excellence standards.
• Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management. Handles 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 focus.Qualifications
• A minimum of a Bachelor's degree is required preferably in engineering, technical, or life science.
• A minimum of 4 years of experience in a GMP and/or ISO regulated industry is required.
• Experience in the Medical Device/ Pharmaceutical industry is preferred.
• Knowledge with FDA CFR Part 820 and ISO 13485 is preferred.
• Auditing background is an asset.
• Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and effects analyses is strongly preferred.
• Blueprint literacy including GD&T is preferred.
• Strong in root cause analysis skills are required.
• Experience and/or knowledge with machining manufacturing processes and injection molding are preferred.
• Six Sigma, Lean, or ASQ Certification and trainings are preferred.
• This position is located in Raynham, MA and will require up to 20% travel.Primary Location
Depuy Orthopaedics. Inc. (6029)Job Function