Associate Director - Corporate Quality Compliance (QMS)

About the role

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.

Responsibilities

• Arcitect 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.
• Lead a team of quality professionals who define, implement, and monitor the global QMS at Zimmer Biomet.
• 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.
• 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.

Qualifications

• 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.
• 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.

Skills

• 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.
• 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.

Benefits

• Up to 20% travel expected.
• Comprehensive bonus also provided.

Pay

$130,000 - $165,000 base salary.

Schedule

N/A