Quality Engineer

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: Supports and continuously improves the operations and quality system elements for the facility involved in the distribution, repackaging, relabeling, and value-added services for manufactures of medical devices who contract Owens & Minor’s Outsourced Logistics business unit for 3PL services. Serves as quality contact for assigned areas of oversight and is accountable for all quality outputs for those respective areas.  Supports defect reduction and problem resolution using a variety of investigative and analytical tools.  The ideal candidate must be a critical thinker and open to working in a fast-paced environment that emphasizes detail, tactical, and process-improvement support. The individual will contribute to achieving the milestones and objectives for their assigned areas of responsibility.

The anticipated salary for this position is $70,000 annually.  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:

• Supports programs such as quality metrics, management reviews, cost of quality, training, risk management, change management and authoring and managing Standard Operating Procedures (SOPs) and Work Instructions (WIs).

•  Supports operations to ensure compliance for the distribution, repackaging, relabeling, and containment of medical devices.  

• Supports operations to define quality objectives for key performance indicators (KPIs).  Supports the implementation of associated measurement systems and collects and monitors data for relevant trends of KPIs. 

• Supports oversight of quality management system activities to ensure that Process Exceptions, Non-conformance, and CAPAs are opened as needed and are resolved in a timely and effective manner; supports root cause analysis through training and hands-on assistance.

•  Supports validation or qualification tests of new or existing equipment, processes or software in accordance with internal protocols as applicable.

• Acts as the quality contact for 3PL client(s).  Will be accountable for ensuring procedures and processes for receiving, storage, value added services (if applicable), and shipping are established and current for the client(s).

Qualifying Experience:

• Bachelor’s degree (B.S.) in Engineering or a Science related field required

• Up to three (3) or more of quality engineering experience in a manufacturing or logistics environment preferred

• American Society for Quality (CQA, CQBA, CQE, CQM/OE) and/or Regulatory Affairs Professionals Society or comparable certification a plus

• Any combination of education and experience to meet the above requirements will be considered

• Microsoft Application experience with Word, Excel, PowerPoint, and Outlook required.

Knowledge, Skills, Abilities:

• Limited knowledge of quality engineering/quality control principles; basic knowledge of statistics a plus

• Medical Device experience, knowledge of 21 CFR Part 820 and or ISO 13485 preferred 

• Basic understanding of Title 21 Code of Federal Regulations and other Federal and State regulations applicable to O&M's activities preferred

• Working knowledge of an electronic quality management system is a plus

• Ability to work independently and as part of a team

• Possesses basic oral and written communication skills.; basic interpersonal skills

• Basic analytical capabilities with demonstrated skill in evaluating reports, identifying issues, noting trends, and reporting to these observations to management

• Must be able to analyze and define problems, collect data, establish facts and draw conclusions potentially with assistance from senior members of team

• Other duties as assigned

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.