Quality Operations Manager

At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350+ facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers—and their patients—are at the heart of what we do.

Our mission is to empower our customers to advance healthcare, and our success starts with our teammates. 

Owens & Minor teammate benefits include:

• Medical, dental, and vision insurance, available on first working day

• 401(k), eligibility after one year of service

• Employee stock purchase plan

• Tuition reimbursement

Job Summary

The Quality Manager will establish strategies, systems and processes to support an effective Quality Management System. He/she will provide leadership and guidance on validation, risk assessment, resolution of manufacturing deviations, complaint investigations and ensure effective and timely closure of CAPAs. The Quality Manager will plan and develop capabilities and strategies to support the growth of
the business. He/she will act as the Quality Management Representative for the site. He/she will implement effective Quality Systems and ensure regulatory compliance to medical device regulations such as 21 CFR 820, ISO 13485, Canadian Medical Devices (CMDCAS), IVDD, ANVISA (Brazilian Health Authority). The Quality Manager will host external audits from health authorities, notified bodies and customers as needed and ensure manufacturing site inspection readiness. The individual will review and report metrics on compliance of Quality Operation performance.

Core Responsibilities:

• Ensure that processes needed for the quality management system are established, implemented, and maintained to meet regulatory requirements such as: 21 CFR 820, ISO 13485 and Canadian Medical Devices (CMDCAS).

• Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products comply with applicable quality standards and requirements.

• Promote awareness of regulatory and customer requirements throughout the organization.

• Implement quality engineering and lean practices to reduce defects, scrap and waste.

• Manage the QC testing and release of manufactured product in a timely fashion.

• Conduct internal, key vendor, and product quality audits as prescribed.

• Represent the Company for all audits conducted by the FDA, notified bodies, and partner companies.

• Ensure that all employees are trained in the Company’s Quality system, as required.

• Implement and execute investigations, corrective and preventive action to reduce internal nonconformance and external customer complaints.

Qualifications/Education/Experience Required:
Education
Required:
• Bachelor’s degree in a science, business, engineering, or related discipline.
Qualifications:
• A minimum 7 years of experience working in a Medical Device, pharmaceutical, regulated environment role
• Minimum of 5 years management experience
• Current working experience with FDA, ISO 13485 and Canadian medical device regulations.
• Experience in managing a QSR compliant quality system and specific Design Control activity.

Principal Accountabilities:

• Act as the Quality Management Representative.

• Maintain and enhance the Quality Management System to ensure ongoing compliance with the FDA Medical Device, ISO 9001, and ISO 13485 requirements, as well as the Corporate and sector Quality Management System Requirements.

• Act as host for external audits.

• Manage the Internal Assessment, Management Review, Complaint Handling, and Corrective/Preventative Action process.

• Provide direction and coordination of efforts of the Quality Assurance Resources to ensure overall effectiveness in Quality Assurance support of the manufacturing departments and to proactively identify and execute quality improvement programs.

• Ensure the communication, implementation, and promotion of the O&M values, vision, mission, and foundations as a means for delivering manufacturing results.

• Contribute to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results.

If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.

Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.