What are the responsibilities and job description for the Quality Auditor position at Zimmer Biomet?
Requisition Number
AMER27295Employment Type
Full-timeLocation
WarsawJob Summary
Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.The primary job responsibility is auditing 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.
Principal Duties and Responsibilities
Execute audits through the evaluation of operations/processes, the review of documents and records, and interviews with employees for compliance. 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.Expected Areas of Competence
• Must have basic knowledge of manufacturing processes and ability to work towards a thorough knowledge 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. • Must develop a thorough knowledge of QSR regulations, ISO guidelines, MDD, CMDR and Zimmer policies and procedures. • Must be reliable and capable of working with minimal supervision. • Must be able to manage stressful situations and to handle controversial issues; firmly adhering to the principles of the regulations and guidelines.Education/Experience Requirements
• A Bachelor's Degree in a technical discipline and 3-5 years of audit experience required. • ASQ certifications such as CQA, CQE are desirable.Travel Requirements
Up to 20%Additional Information
At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.
EOE/M/W/Vet/Disability
Salary : $66,900 - $84,700
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