Zimmer Biomet is a world leader in medical devices specialized in musculoskeletal care.

 

By joining us, you will actively contribute to improve the quality of life of thousands of people around the world. You will participate in the development of innovative solutions that support orthopedic surgeons and clinicians in alleviating pain and improving the quality of life for their patients.

 

We care deeply about making our mission a reality. We believe it is important to protect our community and our environment. In addition to your professional responsibilities, you will have the opportunity to get involved in one of our social, charity or environmental initiatives.

 

 

Job Summary

Provide leadership and guidance in maintaining Zimmer Biomet Products and Quality Management System (QMS) compliance to ensure efficiency and compliance with international medical device regulations and standards.

 

Principal Duties and Responsibilities

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 throughout 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.Share knowledge and expertise with colleagues

 

Expected Areas of Competence (i.e., knowledge, skills and abilities)

Expertise with Design & Change Control, (Cyber Security) Risk Management, and QMS maintenance related to Software as a Medical Device (SaMD).Proven leadership in a global team environment and ability to build relationships outside the department (R&D, Regulatory Affairs, Product Management).Expertise with product related Quality Management System processes such as: Health Hazard Evaluations, Complaint Handling, Product Quality Signals, Post Market Surveillance and Corrective and Preventive Actions.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,IEC 62366, MDSAP, EU MDRResults-oriented approach, must demonstrate the ability to deliver and meet deadlines while maintaining the highest level of product quality. Strong English communication skills, both verbal and written, across various organizational levels.Proficient using Microsoft Office Suite tools.Practical knowledge and experience with Internal and External (Regulatory body) audits.

 

 

Education/Experience Requirements

Bachelor's degree in engineering, biology, computer science or alternative degree program with certification as a quality engineer (e.g. ASQ, Exemplar). 10 to 15 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 Requirements

Up to 10%.

 

Salary Expectations: 

$120,000-$150,000 USD 

$170,000-$190,000 CAN

What You Can Expect How You'll Create Impact What Makes You Stand Out Your Background Travel Expectations
EOE/M/F/Vet/Disability