Quality Manager

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. For over 140 years, Owens & Minor has delivered comfort and confidence behind the scenes, so healthcare stays at the forefront, helping to make each day better for the hospitals, healthcare partners, and communities we serve. Powered by more than 14,000 teammates worldwide, Owens & Minor exists because every day, everywhere, Life Takes Care™.

Global Reach with a Local Touch

• 140+ years serving healthcare

• Over 14,000 teammates worldwide

• Serving healthcare partners in 80 countries

• Manufacturing facilities in the U.S., Honduras, Mexico, Thailand and Ireland

• 40+ distribution centers

• Portfolio of 300 propriety and branded product offerings

• 1,000 branded medical product suppliers

• 4,000 healthcare partners served

Benefits

• Comprehensive Healthcare Plan - Medical, dental, and vision plans start on day one of employment for full-time teammates.

• Educational Assistance - We offer educational assistance to all eligible teammates enrolled in an approved, accredited collegiate program.

• Employer-Paid Life Insurance and Disability - We offer employer-paid life insurance and disability coverage.

• Voluntary Supplemental Programs – We offer additional options to secure your financial future including supplemental life, hospitalization, critical illness, and other insurance programs.

• Support for your Growing Family – Adoption assistance, fertility benefits (in medical plan) and parental leave are available for teammates planning for a family.

• Health Savings Account (HSA) and 401(k) - We offer these voluntary financial programs to help teammates prepare for their future, as well as other voluntary benefits.

• Paid Leave - In addition to sick days and short-term leave, we offer holidays, vacation days, personal days, and additional types of leave – including parental leave.

• Well-Being – Also included in our offering is a Teammate Assistance Program (TAP), Calm Health, Cancer Resources Services, and discount programs – all at no cost to you.

Job Description: Regulatory & Quality Compliance Manager has accountability for Regulatory, Quality and Compliance issues, including state, federal and local regulatory issues, risk management issues, training and development, product compliance, special handling regulations and related information technology requirements. Accomplishes goals through matrix management and oversight of resources and teammates supporting 3PL logics and value-added services for medical device manufacturers.

The anticipated salary for this position is $115,000-$120,000 annually with a 10% AIP eligibility.  The actual compensation offered may vary based on job-related factors such as experience, skills, education, and location. This position is onsite at the Owens & Minor distribution center in Louisville, Kentucky.

Core Responsibilities:

• Develops, maintains and manages the Company’s Quality system--ensuring that processes needed for the quality management system are effectively established, implemented and maintained.

• Promotes the awareness of regulatory and 3PL client requirements throughout the organization.

• Reports to top management on the performance of the quality management system.

• Responsible for determining if the Quality Management System is suitable and effective

• Ensures that quality documentation is current and is properly authorized and controlled.

• Ensures the quality testing and release of manufactured product in a timely fashion. Ensures the release of products comply with applicable internal requirements.

• Ensures internal, key vendor and product quality audits are completed as prescribed.

• Ensures Design Transfer is properly completed for product changes and new product implementation.

• Establishes and maintains an adequate organizational structure with sufficient personnel to ensure conformance with quality systems requirements. Manages personnel activities including hiring, training, development and performance management

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

• Represents the site for all audits conducted by the FDA, notified bodies, partner companies and corporate audits. Acts as the quality management re