"Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.
As a key contributor within our Supplier Quality organization, you will be responsible for the supplier related quality engineering processes at manufacturing sites and for raw material suppliers engaged in the production of DePuy Synthes products. You will also be responsible for providing complex support for products that require validation at suppliers and external manufacturers.
The Supplier Quality Engineer will conduct audits to good manufacturing practices, international organization for standardization and any other applicable standards. He/she 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 experience level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
The Supplier Quality Engineer will address and correct product and process complaints. He/she will report on contract manufacturer performance metrics and management reviews. You will lead audits of all quality system categories to assess compliance to process excellence standards. You will also 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.
- Implement SQ strategy and follow Supplier Quality standards
- Lead supplier related Non-Conformities (NC and SCAR's) and Corrective and Preventive Actions (internal CAPA's)
- Handle supplier change requests (SCR) with Procurement
- Support Process Validations at suppliers
- Lead PVE's (First Article Inspection, Control Plans, Critical to Quality, Capability studies)
- Provide to product investigations related to SCAR and internal CAPA
- Support Procurement executing supplier transfer projects
- Support for Quality Agreement and Change Agreements, supplier assessments and supplier audit process
- Bachelor's Degree in Engineering, Life Science, or related discipline.
- A minimum of 5 years of experience in a GMP and/or ISO regulated industry.
- Strong communication, collaboration, and analytical skills.
- Strong root cause analysis skills.
- First experience managing suppliers.
- Business fluency in English and German.
- Experience in the medical device and/or pharmaceutical industry.
- Supplier quality experience.
- Both, FDA and ISO regulations knowledge: FDA CFR Part 820 and/or ISO 13485.
- Auditing background.
- Experience or knowledge with machining manufacturing processes.
This position will be based in Tuttlingen, Germany. This role requires up to 20% travel within Europe.
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.
Synthes Tuttlingen (7131)