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Senior Supplier Quality Engineer
Horseheads, New York
Requisition ID: 7352171217
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 Senior Supplier Quality Engineer (SQE) provides overall quality assurance and quality engineering leadership in the management of contract manufacturing suppliers, including Finished Good Medical Devices, Direct and Indirect Material/Service Suppliers which can impact Johnson and Johnson production and/or sale of J&J product.
You'll conduct day-to-day and strategic activities in the lifecycle management of suppliers. As a Sr. SQE, you will establish clear expectations and collaborate with internal and external partners that lead to consistent, reliable, quality products and services.
- Participate in the selection, categorization and qualification of suppliers and associated processes.
- Add, remove and update quality system supplier information and ensure accurate supplier information on the Approved Supplier List.
- Establish and provide relevant information detailed in supplier quality agreements and supplier change agreements.
- Execute and document supplier non-conformance reports (NCRs), Supplier Corrective Action Requests (SCARs) and Corrective and Preventive Actions (CAPAs).
- You will define and lead actions related with Supplier Change Requests.
- Lead and support supplier assessments and supplier audits for compliance to regulations, agreements, standards and documented processes.
- Guide the development and improve comprehensive measurement systems for the SQ program and supplier quality performance. The Sr. SQE may report on such metrics at Quality System management reviews.
- Ensure systems to measure, assess risk and escalate quality events. Manage quality events to identify, bracket, correct, control and prevent defects.
- Lead and document internal supplier quality procedure change efforts. The Sr. SQE will adhere/comply with and utilize multifaceted industry and process excellence standards on an expert level, including good manufacturing practices (GMP), equipment engineering system (EES), international organization for standardization (ISO) and country/governmental regulations. FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.
- Support local plant/facility based initiatives and projects.
- A Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred.
- You will have a minimum of 4 years of experience in a GMP and/or ISO regulated industry. Experience in the medical device and/or pharmaceutical industry is preferred.
- You are knowledgeable in FDA and ISO regulations. FDA CFR Part 820 and/or ISO 13485 knowledge is preferred.
- Auditing background is preferred.
- Strong communication, partnership, and analytical skills are required.
- You have demonstrated strong root cause analysis skills.
- Experience and/or knowledge with machining manufacturing processes and injection molding is preferred.
- Six Sigma, Lean, or ASQ Certification and trainings are preferred.
- You have experience with CNC Milling and Turning; Press Breaking and Punching, Assembly; Metal Laser Etch; Silk-Screen, and Metal Processing such as passivating anodizing and heat treating.
- The preferred location for this position is Elmira, New York.
- The position will require up to 25% 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 are equalopportunity employers, and all qualified applicantswill receive consideration for employment withoutregard to race, color, religion, sex,sexual orientation, gender identity, geneticinformation, national origin, protected veteranstatus, disability status, or any othercharacteristic protected by law.
United States-New York-Horseheads
Depuy Orthopaedics. Inc. (6029)