Supplier Quality Senior Engineer 100%

Vor 2 Tagen

Winterthur, Schweiz Zimmer Biomet Vollzeit

-Requisition Number
EMEA09210
Employment Type
Full-time
Location
Winterthur

Founded in 1927 and headquartered in Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products, sports medicine, biologics, extremities, trauma products, and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

For our production site based in Winterthur (Switzerland), we are looking for a:
**Supplier Quality Senior Engineer 100% M/F/d**

**Job Summary**:
The Supplier Quality Senior Engineer will support the overall Supplier Quality Management. This position must drive incoming quality by evaluating new and existing suppliers, driving the incoming quality verification program at the Company, and resolving supplier issues to closure in a timely manner. SQE will provide supplier qualifications, material issue resolution, driving supplier corrective actions, and maintain the approved manufacturer list. Contributes to optimize added value and business success by maintaining, reviewing, operating, and further developing Zimmer Biomet process oriented organizational system (incl. suppliers). Audits Suppliers per compliance with regulatory and corporate requirements.

**Your main responsibilities**:

- Managing and monitoring implementation and effectiveness of corrective actions related to NCR findings
- Assisting suppliers in developing strategies for corrective action and preventive action
- Identifying risks to products and processes that trace to deficient quality systems, uncontrolled critical parameters, changing regulatory requirements, and changing technical requirements
- Collects and analyzes quality metrics from various quality systems and develops reports as needed for SRB review. Provides recommendations based on trends
- Collaboration with Sourcing to track ongoing supplier quality performance and work with suppliers on quality issues
- Approve supplier selection through robust qualification processes
- Develop positive relationships and work closely with Global Supplier Management to manage and implement supplier changes, New Product Introductions, and transfer
- Support audit management during notified body audits as a frontroom / backroom member or SME
- Member of Material/Supplier Review Board
- Carrying out external system and process audits at suppliers as a lead auditor
- Developing, negotiating and concluding quality assurance agreements with subcontractors
- Carrying out product audits and desktop audits
- Following-up regulatory and corporate requirements
- Support Global Audit group, internal audit group for EMEA audits

**Your qualifications and experience**:

- Position requires a sound technical background (university degree, technical degree or equivalent of technical nature)
- Quality Manager training with Diploma examination (SAQ or equivalent) and Auditor training with Diploma examination (SAQ or equivalent) required
- Experience in manufacturing industry (preferably medical devices or pharma) and in a quality organization
- Familiar with a variety of office software packages including MS Word, Power Point, Visio, Excel, SAP and MS Project etc.
- Broad knowledge of regulatory requirements (FDA / ISO / GMP / MDD etc.)
- Understanding of all engineering fields and internal processes to be audited
- Ability to be CAPA owner
- Industry know how in medical devices and/or related fields
- Knowledge of production and business processes
- Good problem-solving ability and analytical skills, strong sense of initiative, follow-through and attention to detail
- Excellent interpersonal skills
- Good report, business correspondence & procedure-writing skills
- Cross Boundary teamwork
- Interpersonal/intercultural impact
- Details and in depth analysis
- Continuous learning
- Good command of English and German both verbal and written

**Travel requirements**:
This job position has a willingness to travel approx. 20% EMEA wide

**Zimmer Switzerland Manufacturing GmbH**

Frau Kübra Dur

Human Resources Generalist

Sulzerallee 8

8404 Winterthur

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