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Job Summary

This role develops, implements, and manages the Zimmer Biomet Site Internal Audit Program to assess and ensure compliance to the FDA Quality System Regulations, ISO 13485 Quality System Standards and other applicable regulations. This role also manages the Zimmer Biomet Site External Audit Facilitation Program and maintains necessary records of site inspections and certifications.

Principal Duties and Responsibilities:

Develop and manage the Internal Audit Program for Zimmer Biomet sites. Track audit activities and manage audit schedule.

Hire, train, develop, and manage corporate audit personnel to effectively support and continuously improve the corporate audit process.

Facilitate and manage the External Audit support program

Compile audit and inspection findings to identify company compliance trends and risks.

Partner with key stakeholders on audits, inspections by and inspection responses to FDA, Notified Bodies, and Competent Authorities.

Facilitate, along with senior management, the achievement of Quality Systems objectives and any other regulatory objectives (e.g., QSR training, Quality Systems initiatives, etc).

Maintain metrics and data for tracking and trending of audits and present to management.

Maintain records of manufacturing sites’ notified body certifications and FDA inspections.

This is not an exhaustive list of duties or functions and might not nece s sarily comprise all of the e s sential functions for purposes of the Americans with Disabilities Act.

Expected A r eas of Competence (i.e., knowledge, skills and abilities)

• Thorough knowledge of state-of-the-art audit practices.

• Lead and motivate team members through feedback and stretch assignments.

• Establishes and maintains high levels of credibility. Collaborates effectively across the organization, leverages resources from other parts of the organization to build commitment and achieve results.

• Extremely organized, detail-oriented, with a high degree of professionalism, diplomacy, discretion and judgment.

• Teamwork and customer focus oriented.

• Demonstrate ability in selecting, interviewing, training, coaching, motivate, discipline, and direct people.

• Must possess good writing skills and be familiar with both the scientific and vernacular vocabularies.

• Good knowledge of applicable government specifications, standards and regulations such as Quality System Regulation and ISO standards.

Education/Experience Requi r ements

• This position requires a Bachelor’s Degree preferably in engineering or a related discipline with 6-8 years of work experience in quality functions, or an advanced degree (ex. Masters) in a related discipline with 4-6 years experience.

• Quality discipline certification preferred (e.g., CQA, CQE, CQM, etc.).

• Medical Device regulations knowledge and experience required.

• Experience in dealing with representatives from Food and Drug Administration or other regulatory agencies.

• Quality Engineering Certification (ASQ) a plus.

T r avel Requi r ements

Up to 10%

What You Can Expect

How You'll Create Impact

What Makes You Stand Out

Your Background

Travel Expectations

EOE/M/F/Vet/Disability