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 recognised.
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 as well as applicable standards and regulations (e.g. 21 CFR Part 820, ISO *****:****, EU MDR ********, MDD *****/EEC, etc).
How You'll Create Impact 50% - 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.
20% - Follow-up audit results by seeking appropriate corrective actions if deficiencies are noted.
Track implementation of corrective actions and verify actions for effectiveness.
10% - Support management on tracking audit activities and administration of audit schedule.
10% - Support external audits including interfacing with regulatory agencies and registrars if necessary.
10% - Lead and support projects and initiatives to achieve Quality Systems objectives and any other regulatory objectives (e.g., QMSR training, Quality Systems initiatives, etc).
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 working knowledge of medical device design and manufacturing processes and the ability/curiosity to work towards in-depth understanding of Zimmer Biomet processes and products.
A strong background in math, chemistry, engineering, software or microbiology is desirable to enable the individual to evaluate technical systems and processes.
Demonstrated knowledge of Quality Systems Regulations, ISO requirements and guidelines, MDR/MDD, and be able to quickly develop a thorough understanding of Zimmer Biomet 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.
Your Background A Bachelor's Degree is required.
A degree in a technical discipline is preferred.
6-8 years of experience in a Quality role with at least two years in quality audit required; prefer at least five years of quality audit experience.
Strong 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: Global Travel up to 60% EOE/M/F/Vet/Disability