Quality Manager

Responsibilities

• Develop, maintain, and manage the Company’s Quality Management System (QMS) to ensure effective implementation and maintenance.
• Promote awareness of regulatory and 3PL client requirements throughout the organization.
• Report to top management on the performance and suitability of the quality management system.
• Ensure quality documentation is current, properly authorized, and controlled.
• Oversee quality testing and timely release of manufactured products in compliance with internal requirements.
• Manage internal, vendor, and product quality audits as prescribed.
• Lead personnel activities including hiring, training, development, and performance management for the quality team.
• Act as the site representative for audits conducted by the FDA, notified bodies, and partner companies.
• Ensure processes meet ISO 13485, ISO 9001, FDA QSR, and other regulatory requirements.
• Support EHS policies and comply with all local EHS legislation and codes.

Requirements

• Bachelor's degree in engineering or a science-related disciplinary area.
• 7+ years of experience in a QSR (GMP) manufacturing environment involving medical device hardware/software, supply chain, or operations.
• 2+ years of supervisory experience.
• Strong knowledge of FDA regulations and cGMP compliance standards.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, and Outlook).
• Ability to travel approximately 25-40%.

Preferred Qualifications

• Knowledge of DEA and human tissue regulations.
• Working knowledge of distribution, regulatory, and legislative environments.
• Demonstrated skill in designing and interpreting regulatory action plans.
• Proven ability to serve as a lead liaison with Regulatory Agencies.

Benefits

• Comprehensive healthcare plans (medical, dental, and vision) starting on day one.
• Educational assistance for eligible teammates in accredited programs.
• Employer-paid life insurance and disability coverage.
• 401(k) and Health Savings Account (HSA) options.
• Paid leave including holidays, vacation, personal days, and parental leave.
• Well-being support through the Teammate Assistance Program (TAP) and Calm Health.

About the Company

Owens & Minor is a global healthcare solutions company providing essential products, services, and technology solutions that support care delivery in leading hospitals, health systems, and research centers around the world. Powered by more than 14,000 teammates worldwide, we deliver comfort and confidence behind the scenes so healthcare stays at the forefront.