The primary job responsibility for this position is to audit Zimmer’s worldwide Quality Systems and processes for compliance to the applicable company policies and procedures, the Quality System Regulation (21 CFR Part 820), ISO 13485:2003, the Medical Device Directives (MDD), and all other applicable standards and regulations.
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 management on tracking audit activities and administration of audit schedule.
Support external audits including interfacing with regulatory agencies and registrars if necessary.
Lead and support projects and initiatives to achieve Quality Systems objectives and any other regulatory objectives (e.g., QSR training, Quality Systems initiatives, etc).
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, 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.
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.
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.
About Zimmer Biomet
Zimmer Biomet has been based in Warsaw since it was founded in 1927. Today, Zimmer Biomet has operations in more than 25 countries around the world and sells products in more than 100 countries.
Our global team designs, manufactures and markets effective, innovative solutions that support orthopaedic surgeons and clinicians in alleviating pain and improving the quality of life for people around the world. Our musculoskeletal technologies and a wide range of related products and services make us partners to healthcare providers in more than 100 countries.
We're building on a strong history of success to enhance the value we provide to healthcare providers and their patients. Zimmer Biomet maintains world-class scientific facilities and resources and collaborates with leading clinicians and researchers around the world. We share a commitment with healthcare providers to find the best technologies, treatments and solutions to deliver high quality, cost-effective patient care.
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