Quality Sr Auditor
Zimmer Biomet

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 talent 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 included, respected, empowered, and recognized.

What You Can Expect

The primary job responsibility for this position is to audit Zimmer Biomet's worldwide Quality Systems and processes for compliance to the applicable company policies and procedures, the Quality System Regulation (21 CFR Part 820), ISO 13485, the Medical Device Directives (MDD), Medical Device Regulation (EU MDR) 2017/745 and all other applicable standards and regulations.

How You'll Create Impact

• Plan audits by preparing and communicating audit plans. Execute audits through the evaluation of operations/processes, the review of documents and records, and interviews of employees for compliance. Communicate audit results through the preparation and publication of audit reports.
• Follow-up audit results by seeking appropriate corrective actions if deficiencies are noted. Track implementation of corrective actions and verify actions for effectiveness.
• Support external audits including interfacing with regulatory agencies and registrars if necessary.
• Assist in achieving other regulatory objectives (e.g., QSR training, Quality Program applications) at the direction of the manager.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

What Makes You Stand Out

• Must be familiar with all aspects and elements of a quality system including but not limited to corrective and preventive action (CAPA), management responsibility, product realization and measurement, analysis and improvement processes.
• Must have basic knowledge of manufacturing processes and the ability to work towards in-depth understanding of Zimmer processes and products.
• A strong background in math, chemistry, engineering or microbiology is desirable to enable the individual to evaluate systems such as machining, sterilization, electrochemical processes, statistical process data, etc.
• Demonstrated knowledge of Quality Systems Regulations, ISO requirements and guidelines, MDD, EU MDR and be able to quickly develop a thorough understanding of Zimmer internal policies and procedures.
• Must be reliable and capable of working with minimal supervision to manage audit planning and execution, and follow-up activities.
• Basic experience or knowledge on issue resolution disciplines (e.g., problem solving/decision making, root cause analysis, etc).
• Must be able to manage stressful situations and to handle controversial issues.
• Highly compliance oriented to firmly adhere to the principles of the regulations and standards.
• Assist in achieving other regulatory objectives (e.g., QSR training, Quality Program applications) at the direction of the manager.

Your Background

• A Bachelor's Degree is required. A degree in a technical discipline is preferred.
• Minimum 5 years of experience in a Quality role with at least one year in quality audit required.
• Intermediate skills in MS Office applications or equivalent required.
• Audit or ASQ certifications such as RABQSA, CQA, CQE are strongly preferred.
• Medical Device regulations knowledge and experience is required.
• FDA or Notified Body experience strongly preferred.

Travel Expectations

Up to 40%

EOE/M/F/Vet/Disability

This job has expired.