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Quality Engineer III - Supplier Quality
Requisition ID: 2247180503
DePuy Synthes Companies is a member of Johnson & Johnson's Family of Companies, and is recruiting for a Quality Engineer III - Supplier Quality located in Warsaw Indiana.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic 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 Quality Engineer III - Supplier Quality provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of Johnson and Johnson products.
The Quality Engineer III - Supplier Quality will conduct audits to good manufacturing practices, international organization for standardization and any other applicable standards. They will provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. You will 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). We need you to address and correct product and process complaints. They will report on contract manufacturer performance metrics and management reviews. You'll oversee audits of all quality system categories to assess compliance to process excellence standards. We need you to ensure comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management. They will handle complex technical issues for manufacturing processes that are to be transferred to satellite facilities. You'll 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 5 years 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 required.
- 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 with machining manufacturing processes, injection molding, and/or additive manufacturing is preferred.
- Six Sigma, Lean, or ASQ Certification and/or trainings are preferred.
- This position will be based in Warsaw, IN and require up to 25% travel, including possible international travel.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.Johnson & Johnson Family of Companies areequal opportunity employers, and all qualifiedapplicants will receive consideration for employmentwithout regard to race, color, religion,sex, sexual orientation, gender identity, geneticinformation, national origin, protected veteranstatus, disability status, or any othercharacteristic protected by law.
Depuy Orthopaedics. Inc. (6029)