J&J Family of Companies Senior Engineer, Source Quality in Trenton, New Jersey
DePuy Synthes Companies is a member of Johnson & Johnson's Family of Companies and is recruiting for a Senior Engineer, Source Quality located in Raynham, MA. Considerations will be given to candidates who are located within commuting distance of JNJ sites in New Jersey and Pennsylvania.
DePuy Synthes Companies of Johnson & Johnson is the largest, most creative and comprehensive orthopedic business in the world. These companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two excellent 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 creative, comprehensive solutions, we are encouraged to advance patient care in greater ways than either company could accomplish on its own.
•Provides quality engineering leadership in the management of select contract manufacturing and supplier sites engaged in the production and delivery of Johnson and Johnson products and services.
•Responsible for technical leadership in establishing quality expectations at the supplier, to include process changes in partnership with Source Quality and New Product Development (NPD) Teams
•Partner with NPD team to support successful launches at suppliers.
•Conduct supplier visits emphasizing quality improvement and compliance with good manufacturing practices, ISO and other applicable standards.
•Provide product team support for quality system requirements and supplier auditing, compliance assessment, and for support of sustaining manufacturing processes.
•Provide Quality Engineering support to suppliers including inspection technique support, product non-conformances, verification/validation activities, CAPA and change management
•Address and support investigation of product issues to include product and processing complaints.
•Apply industry and process excellence tools and standards in daily quality operation activities, to include Good Manufacturing Practices (GMP), equipment engineering system (EES), and ISO.
•Report on supplier performance metrics during quality and management reviews.
•Lead supplier visits focusing to assess compliance to process excellence standards.
•Ensure comprehensive measurement systems to monitor effectiveness of quality and reliability. Identify, bracket, correct and prevent defects. Present reports to management.
•Evaluating and implementing improved manufacturing engineering performance management systems and tracking tools, as well as facilitating resolution of complex technical, quality and operational problems.
•A minimum of a bachelor’s degree is required. A degree in Engineering, Life Science, or related discipline is preferred.
•A minimum of 4 years of experience in a highly regulated industry is required.
•Experience in the Medical Device industry is an asset.
•Experience in Operations Source Quality is preferred.
•ISO regulations knowledge is required.
•FDA CFR Part 820 and ISO 13485 knowledge preferred.
•Auditing background is an asset.
•Strong communication, partnership, and analytical skills is preferred.
•Strong in root cause analysis skills is preferred.
•Experience with process validation is preferred
•Experience or knowledge with machining manufacturing processes, injection molding and/or electronics manufacturing an asset.
•Six Sigma, Lean, or ASQ Certification and training an asset.
•This position may require up to 25% travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Massachusetts-Raynham-325 Paramount Drive
United States-New Jersey, United States-Pennsylvania
Medical Device Business Services, Inc (6029)
J&J Family of Companies
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