Job description

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.

What You Can Expect

Contribute to maintain Zimmer Biomet Products and Quality Management System (QMS) compliance to ensure efficiency and compliance with international medical device regulations and standards.

How You'll Create Impact

Identify areas for design improvement and suggest how design parameters could affect quality measures in a post market phase.
Provide leadership for quality engineering projects for the entire product lifecycle from concept through to maintenance and retirement.
Analyze and review data for product Verification & Validation.
Analyze, review and approve design control and risk management documentation for compliance to QMS and standards.
Work closely with Product management, Quality, Regulatory and other departments to ensure that QMS requirements are effectively established and maintained, with a proactive and preventive risk-based approach.
Ensure the relevance, adequacy and effectiveness of the QMS and report periodically on quality system performance. Evaluate opportunities for improvement and lead established initiatives and action plans.
Contribute to Quality Management System maintenance, evaluate health hazards related to product issues, coordinate product holds as applicable, and provide improvement through Corrective and Corrective actions within established deadlines.
Formulate procedures for Zimmer products and processes.
Perform internal audits and support readiness for both corporate and external audits.

What Makes You Stand Out

Experience with Design & Change Control, (Cyber Security) Risk Management, and QMS maintenance related to Software as a Medical Device (SaMD).
Ability to work in a team environment and build relationships outside the department (R&D, Regulatory Affairs, Product Management).
Experience with product related Quality Management System processes such as: Health Hazard Evaluations, Complaint Handling, Product Quality Signals, Post Market Surveillance and CAPAs.
In-depth knowledge of relevant standards and regulations such as: FDA 21 CFR Part 820 ISO 13485 ISO 14971 IEC 62304 IEC 81001-5-1
Results-oriented approach must demonstrate the ability to deliver and meet deadlines while maintaining the highest level of product quality.
Practical knowledge and experience with Internal and External (Regulatory body) audits.

Your Background

- English proficiency is required (B2-C1)
- Bachelor's degree in engineering, biology, computer science or alternative degree program with certification as a quality engineer (e.g. ASQ, Exemplar).
- 5 to 10 years' experience in quality assurance, preferably in the medical device sector, or an equivalent combination of training and experience.
- Demonstrable (regulated) software development knowledge or experience strongly preferred.
- Certified Lead Auditor or Quality Engineer (CQE) is an asset.

Travel Expectations