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.
The Staff Supplier Quality Development Engineer (Quality Engineer 4), will work with a team to develop suppliers in reducing the level of risk related to DePuy Synthes products and services by identifying quality capabilities and implementing supplier quality improvement plans across the entire supplier base. Other duties include:
• Lead product/process audits, quality systems audits, and engineering reviews and drive projects and actions to mitigate identified risk areas.
• Lead activities to proactively identify and mitigate risk at suppliers.
• Lead quality systems and product process audits to good GMPs, ISO, FDA and other applicable standards.
• Lead engineering reviews of high risk products and services sourced from suppliers.
• Establish, implement and monitor supplier risk mitigation plans.
• Identify and drive implementation of best practices/processes at suppliers, and participate/lead in supplier risk management projects as needed.
• Drive on time completion of supplier risk mitigation projects.
• Ensure management awareness of risks, gain support for mitigation efforts and track progress.
• Utilize multifaceted industry process excellence standards on an expert level in daily quality operations including good manufacturing processes (cGMP), equipment engineering systems (EES), and international organization for standardization (ISO).
• Provides overall quality assurance leadership in the management of select external manufacturing sites and direct material suppliers 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.
• Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management.
• Strong experience in MS Excel, SharePoint and ERP, Nonconformance, Audit compliance and CAPA IT systems preferred.
• A minimum of a Bachelor's Degree is required.
• A Degree in Engineering, Life Science, or related discipline is preferred.
• A minimum of 6 years of experience in a regulated industry is required.
• GMP and/or ISO experience is strongly preferred.
• 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 trainings are preferred.
• The ability to direct a team in meeting departmental goals and objectives, to 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 is located in Westchester PA and will require up to 25% travel.