Offer summary

Qualifications:

Bachelor's degree in engineering, biology, computer science, or a related field with quality engineer certification., 5 to 7 years of experience in quality assurance, preferably in the medical device sector., In-depth knowledge of relevant standards and regulations such as FDA 21 CFR Part 820 and ISO 13485., Strong English communication skills, both verbal and written, with proficiency in Microsoft Office Suite..

Key responsabilities:

Provide leadership in maintaining compliance with the Quality Management System (QMS) and international medical device regulations.

Analyze and review data for product Verification & Validation and approve design control documentation.

Collaborate with various departments to ensure effective establishment and maintenance of QMS requirements.

Support internal audits and coordinate product holds while leading improvement initiatives.

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

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.

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 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 Development, 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 and maintain procedures for Zimmer products and processes.
Support internal audits and readiness for both corporate and external audits.
Share knowledge and expertise with colleagues

What Makes You Stand Out

Experience Implementing Design & Change Control, (Cyber Security) Risk Management, and QMS maintenance related to Software as a Medical Device (SaMD) or Medical Device with integrated/embedded software.
Proven leadership in a team environment and ability to 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
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 MDR

Results & Solutions-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.

Your Background

Bachelor's degree in engineering, biology, computer science or alternative degree program with certification as a quality engineer (e.g. ASQ, Exemplar).
5 to 7 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.
Strong French communication skills, both verbal and written is an asset.

Travel Expectations

Up to 10%.

Expected Compensation Range

$80-88k annually.

EOE/M/F/Vet/Disability

4685

Required profile