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 13485:2003, the Medical Device Directives (MDD), and all other applicable standards and regulations.
Principal Duties and Responsibilities
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).
Expected Areas of Competence
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.
At least seven 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.
Up to 60%