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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.

+ The anticipated salary range for this position is .$60,200.00 - $111,800.00 USD Annual. The actual compensation offered may vary based on job related factors such as experience, skills, education and location

Position Summary

Quality Engineer I will establish, support, and continuously improve the quality system for one or more facilities involved in the distribution, repackaging, and relabeling of medical devices. Serves as key quality contact for assigned areas of oversight. Drives reduction of

defects and problem resolution utilizing a variety of investigative and analytical tools

Responsibilities

Initiates and administers programs such as quality metrics, management reviews,cost of quality, training, post-marketing surveillance, risk management, change management and authoring and managing Standard Operating Procedures (SOPs) andWork Instructions (WIs).

• Works with operations to define quality objectives for key performance indicators(KPIs). Implements associated measurement systems and monitors relevant trends,providing analysis, and interpretation of KPIs for data driven decision making asapplicable.

• Provides oversight of associated quality management system activities to ensure that CAPAs are opened as needed and are resolved in a timely and effective manner;

supports root cause analysis through training and hands-on assistance.

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

• Manages and improves related Quality Program activities (i.e. Master Validation Plan) by designing protocols that involve proper sampling techniques, design of experiments, testing, and statistical rationale as applicable.

Education & Experience

Bachelor’s degree (B.S.) in Engineering or Science required.

• Three (3) or more years of quality engineering experience in a manufacturing

environment required.

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

• Or any combination of education and experience to meet the above requirements.

Knowledge Skills and Abilities

Clear understanding of quality engineering/quality control principles; working

knowledge of statistics, Minitab and/or other statistical software experience.

• Experience in a medical device manufacturing environment preferred.

• Medical Device experience, knowledge of 21 CFR Part 820, (ISO 13485 a plus)

preferred.

• Working knowledge of Title 21 Code of Federal Regulations and other Federal and

State regulations applicable to O&M's private brand products.

• Working knowledge of electronic quality/regulatory software a plus.

• Ability to work independently and as part of a team.

• Good verbal and written communication skills; strong interpersonal skills.

• Strong analytical capabilities with demonstrated skill in evaluating reports,

identifying issues, noting trends, and reporting to these observations to management.

• Must be able to define problems, collect data, establish facts and draw conclusions.

• Ability to analyze and conclude.

• Ability to motivate and direct the work of teammates in multiple facilities in

designated areas of responsibility.

• Effective project manager with ability to handle multiple tasks simultaneously

prioritizing appropriately.

ADDITIONAL

REQUIREMENTS • Ability to travel on a limited basis, up to 50%.

PREVIOUS JOB PROFILE

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.

Owens & Minor and Accendra Health are now two separate companies. For a limited time, this career site will provide job opportunities for both organizations. Each job description includes the respective company designation, or you can use the company filter tool at the top of the page to sort the listings. Please ensure you confirm which company you are applying to. We are excited to have you here, and thank you for your interest in Owens & Minor and Accendra Health.

Owens & Minor (https://www.owens-minor.com/)

Accendra Health