Zimmer Biomet Holdings Inc logo

Associate Director - Corporate Quality Compliance (QMS)

  • $130,000–$165,000 Per Year
Want to know if you’re a fit?
Upload your resume and let our AI show you.

Skills

  • American Society for Quality (ASQ)unmatched
  • Analysis Skillsunmatched
  • Association for the Advancement of Medical Instrumentation (AAMI)unmatched
  • Best Practicesunmatched
  • Biologyunmatched
  • Biotech and Pharmaceuticalunmatched
  • Certified Quality Engineer (CQE)unmatched
  • Code of Federal Regulationsunmatched
  • Computer Skillsunmatched
  • Consultingunmatched
  • Continuous Improvementunmatched
  • Corporate Complianceunmatched
  • Corporate Policiesunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cross-Functionalunmatched
  • Distribution Servicesunmatched
  • Due Diligenceunmatched
  • FDA (Food and Drug Administration)unmatched
  • Financial Trend Analysisunmatched
  • ISO (International Organization for Standardization)unmatched
  • Interpersonal Skillsunmatched
  • Interpret Regulationsunmatched
  • Leadershipunmatched
  • Maintain Complianceunmatched
  • Management Strategyunmatched
  • Manufacturingunmatched
  • Medical Equipmentunmatched
  • Medical Organizationsunmatched
  • Mergers and Acquisitionsunmatched
  • Microsoft Officeunmatched
  • Multitaskingunmatched
  • Policy Developmentunmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Project/Program Managementunmatched
  • Quality Managementunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Strategic Planningunmatched
  • Systems Maintenanceunmatched
  • Team Buildingunmatched
  • Team Lead/Managerunmatched
  • Technical Leadershipunmatched
  • Writing Skillsunmatched

Description

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 talented 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 inspired, invested, cared for, valued, and have a strong sense of belonging.

What You Can Expect

This position serves as the organization''s subject matter expert on global Quality Management System compliance, providing authoritative knowledge and strategic direction across the full scope of applicable regulations, standards, and international frameworks. This position also leads a team of quality professionals who define, implement, and monitor the global QMS at Zimmer Biomet.

How You'll Create Impact

  • Architect and drive the global Quality Management System strategy, including systemic CAPA programs, quality system enhancements, and cross-functional improvement initiatives that strengthen compliance and operational performance across all manufacturing sites, design centers, and distribution centers.
  • Direct the development, harmonization, and continuous improvement of corporate quality policies, procedures, and processes to ensure sustained compliance with applicable global regulations, standards, and evolving regulatory expectations.
  • Interface with external regulatory bodies - lead strategy for FDA inspections, notified body audits, and other regulatory engagements across the global network, consult on agency communications, and post-inspection commitments.
  • Lead quality due diligence for mergers and acquisitions, designing and executing integration strategies that bring newly acquired entities into full alignment with the Zimmer Biomet Quality Management System.
  • Represent Zimmer Biomet in a leadership capacity within key industry bodies (e.g., AdvaMed, AAMI), translating emerging standards, regulatory trends, and industry best practices into actionable updates to corporate quality policies and procedures.
  • Own and lead the Corporate Management Review and Global Quality Report process end-to-end - through executive presentation and tracking of resulting actions to closure.

What Makes You Stand Out

  • Demonstrated knowledge and experience in interpreting and applying regulations and standards for Quality Management Systems that govern design, manufacturing and distribution of products worldwide including but not limited to FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, EU MDR (EU) 2017/745, Canadian Medical Devices Regulations (SOR/98-282), Japan''s Pharmaceuticals and Medical Devices Act (PMD Act) and MHLW Ministerial Ordinance No. 169, MDSAP
  • Acts in a balanced and ethical manner when dealing in gray areas of regulation.
  • Utilizes leadership and motivational skills sufficient to manage multiple projects and interface with personnel from varied backgrounds and cultures in local and remote locations across all company disciplines and business units.
  • Excellent interpersonal skills - Builds and maintains relationships inside and outside the organization.
  • Exhibits good business sense, makes sound and timely scientific and business decisions.
  • Able to advocate positions in the face of adversity.
  • Excellent oral, writing, and presentation skills.
  • Excellent analytical and problem solving skills.
  • Computer literacy including Microsoft Office Suite.

Your Background

  • Bachelor's degree in life sciences, technical discipline, or business is required. (Master's degree is preferred).
  • 7-10 years of experience in a quality, regulatory or quality compliance role is required. Experience with establishing and/or maintaining quality management systems in a medical device manufacturing organization is strongly preferred.
  • Medical Device regulations knowledge and experience required.
  • FDA or Notified Body experience required.
  • Audit or ASQ certifications such as RABQSA, CQA, CQE are strongly preferred.

Travel Expectations

  • Up to 20%

Expected compensation: $130,000 - $165,000 base salary. Comprehensive bonus also provided.

EOE

Numbers & Facts

LocationNY
IndustryMedical Devices and Supplies
Salary$130,000–$165,000 Per Year
Year Founded1927
Websitehttp://www.zimmer.com/

About Company

Do you find pride and purpose in helping millions of people around the world renew their lives? If so, career opportunities at Zimmer facilities worldwide will be an excellent fit for you. We're looking for remarkable people who can be catalysts for change, collaborate globally and push the boundaries of innovation so that we can continue to make the world a more mobile place. We've found that when you're working to improve others' lives, you start to feel incredibly proud and excited about what you do. Join us and find your fit in a company with passion.

Similar Jobs

See more jobs