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.
Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
For our site in Oberdorf (BL)-Switzerland we are looking for a highly committed Supplier Quality Engineer
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.
Your main tasks will include
Implement SQ strategy and follow Supplier Quality standards
Manage supplier related Non-Conformities (NC and SCAR's) and Corrective and Preventive Actions (internal CAPA's)
resolve complex technical issues
Oversee supplier change requests (SCR) with Procurement
Support Process Validations at suppliers
Manage PVE's – Process verifications (First Article Inspection, Control Plans, Critical to Quality, Gage R&R, Capability studies, FMEA)
Contribute to product investigations related to SCAR, internal CAPA and Field Actions
Support Procurement executing supplier transfer projects
Support for Quality Agreement and Change Agreements, supplier assessments and supplier audit process
Prepare regular report and supplier quality metrics
Support internal/external audit
Support site other facilities Tuttlingen, Balsthal, Hägendorf and Umkirch
Qualifications
A minimum of a Bachelor's Degree in Engineering, Life Science, or related discipline is required
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
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 or knowledge with machining manufacturing processes and injection molding is preferred
Business fluency in English and German is required
This position will be based in Oberdorf, BL and require up to 20% travel, including possible international travel.
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.)
