Quality Assurance

**Requisition Number**: EMEA10197

**Employment Type**: Full-time

**Location**: Winterthur

**Job summary**:
This position will act as Management Representative and Person Responsible for Regulatory Compliance (PRRC) according to (EU) 2017/745 Medical Device Regulation Article 15, 3 (a), (c) & (d) for Zimmer Biomet Winterthur.

Develops and implements local quality systems for departmental processes such as change control and electronic device history records. The Quality Assurance & Regulatory Compliance Associate Director supports development and implementation of global quality systems and system from other process owners.

The position requires professional expertise and interpersonal skills sufficient to manage multiple projects and interface with personnel from all company disciplines and business units.

This position will assist in process improvement projects that involve multiple sites to support system standardization within the EMEA organization and ensure compliant interfaces between these organizations where applicable.

**Your main responsibilities**:

- Act as Management representative
- Develop and implement systems for change control, archiving, training, trending, management responsibility, auditing, supplier management, system validation and receiving inspection. Monitor and improve effectiveness of these systems based on compliance risks and business needs
- Coordinate and develop global quality system programs to leverage systems among all sites
- Work on special projects as develop and coordinate consolidated systems for quality system within EMEA
- Work on special projects as assigned by the management
- Increases knowledge and expertise level on Quality system regulations and standards through formal and informal training
- Ensure compliance to relevant quality system regulations and standards
- Drive quality culture improvement
- Manage Change control and archiving functions/ processes for GMP relevant documents and records.
- Access Quality system strengths/ weaknesses and develop quality plans to ensure compliance to relevant quality system regulations/ standards and drive continuous process improvement.
- Represent Zimmer Biomet Winterthur in corporate review boards
- Drive trend reviews and management reviews
- People management

**Your Qualifications and Experience**:

- B.S. degree in engineering, science, management, or other pertinent area (an MBA degree is preferred) Quality Manager training with Diploma examination or equivalent experience
- 6 to 8 years’ experience in quality assurance, or an equivalent combination of education and experience
- 5 years’ medical device industry experience
- This position requires sufficient professional expertise and interpersonal skills to manage multiple projects and interface with personnel from all company disciplines
- Knowledge of applicable ISO Standards ISO13485, ISO 9001, ISO14971, the Medical Device Directive 93/42/EEC, 2017/745 Medical Device Regulation other relevant European directives, general knowledge of US Quality System Regulations and other applicable Country regulations worldwide
- Good German skills (written/oral)
- Good English skills (written/oral)

**Personal skills**:

- Must be able to work with all levels of employees including hourly production employees through senior management
- This person must possess good communication and organization skills
- Requires the ability to analyze quality system projects and develop project plans to achieve successful implementation of systems
- Must be able to assist in determination of what elements of the quality system can be successfully consolidated between sites
- Must be able to identify and implement consolidated solutions to quality system issues
- Assumes responsibility for professional conduct and efficient use of company resources

**Travel Requirements**:
This dynamic Job position has a willingness to travel up to 20%.