Quality Engineering Teamleader 100%

The Quality Engineering Team Leader has the oversight over budget and personal resources in the Quality Engineering team and the expertise of the processes relevant to the quality engineering department and their activities.Key functions of this position are inspection planning, quality production support (e.g. NCR management) and DMR lifecycle management. These includes quality assurance activities required for New Product Initiatives (NPI), Product and Process Transfers, incoming inspection, in-process and finished device acceptance to ensure that the medical devices manufacture in and distributed by Zimmer Biomet Winterthur are in compliance with company policies and procedures, U.S. Food and Drug Administration (FDA CFR21) QSR 820 regulations, ISO 13485, ISO 14971, Medical Device Regulation (MDD 93/42 EEC) and the Medical Device Directive (MDR 2017/745).

**Your main responsibilities**:

- Personnel management and leadership of the Quality Engineering department
- Responsibility for the department budget
- Establishing and periodic review of G&O's aligned with site strategic plan
- Process Ownership for the procedure in the responsibility of quality engineering
- Ensure that Design Control, Design Transfers and Post Market Engineering activities are handled according to DMR Life Cycle process and Product and Process Changes
- Ensure effective handling of risk-based sampling plans for purchased, incoming, in-process and final product inspection to assure that designed product and processes perform to specifications
- Support review and release of validation activities
- Support review and release of Measurement System Analysis and Test Method Validations
- Ensure adequate NCR support for internal produced products
- Provide quality data for quality trending and management review
- Oversight on product change requests
- Leading Issue Evaluations, CAPAs and other quality improvement projects

**Your qualifications and experience**:

- Bachelor degree (FH) or Advanced diploma of Higher Education (HF)
- Further educations in the field of Quality Assurance (e.g., certified engineer)
- Professional level with at least 5 years of practical experience in the medical device industry or other regulated industry (implantable devices experience preferred)
- At least 2 years of practical experience in quality assurance or related departments
- Demonstrated knowledge of FDA regulations (QSR 820), ISO 13485, Medical Device Directive (MDD 93/42 EEC), Medical Device Regulation (MDR 2017/745)
- Profound knowledge of statistical process control
- Solid background for required quality assurance activities for Design Control and Transfer activities
- Solid background in general quality assurance activities e.g. Inspection planning, NCR-handling, validation assurance
- Good background in project management
- Effective use of Microsoft Office Tools for evaluation, reporting and presenting
- Basic Lean/ Six Sigma knowledge
- Demonstrated leadership skills
- Demonstrated interpersonal and communication skills
- Demonstrated ability to exhibit a positive, energetic approach to teamwork
- Demonstrated problem-solving and troubleshooting skills
- Strong organizational, analytical and time-management skills
- Ability to recognize and prioritize quality issues
- Good command of English and German both verbal and written

**Travel requirements**:
This job position has a willingness to travel up 0-10% EMEA wide

**Zimmer Switzerland Manufacturing GmbH**

Frau Kübra Dur

Human Resources Generalist

Sulzerallee 8

8404 Winterthur