Quality Engineer I

2 weeks ago


Saint Paul, Minnesota, United States Owens & Minor Full time $40,000 - $70,000 per year

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

The anticipated range is $60,000 - $80,000

  • This role requires being on site at least 2 days per week

Position Summary
: The purpose of this position is to provide tactical support with on-going activities required to support existing products within the North America DC Network of Owens & Minor. These activities include but are not limited to providing DC QA oversight for Owens & Minor, overseeing the re-pack/re-box operations, conducting investigations as a result of quality related issues, maintaining accountability of non-conforming product and driving continuous improvement in the assigned DCs.

Responsibilities:
1) Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported as appropriate for the position. 2) Manage self in accordance with the expected behaviors of the Leadership Qualities. 3) Provides support in solving challenging technical problems related to quality issues and technologies. 4) Provides support in the development and implementation of new quality concepts, tools and strategies to improve business practices.

  • Maintain control of all non-conforming products located at the assigned DCs.
  • Conduct random cycle counts of non-conforming product to ensure 100% accountability.
  • Support all new product launches for Owens & Minor.
  • Help to drive continuous improvement at the assigned DCs by conducting Procedure/Process Flow Audits, and Failure Mode/Gap Analysis.
  • Provide QA oversight for Owens & Minor in support of reboxing, kit packing, and product returns at the assigned DCs.
  • Actively participate in the closure of corrective and preventive actions.
  • Oversee and participate in the execution of protocols.
  • Meet all training requirements and effectiveness criteria.
  • Enhances department reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
  • Assist with the development, implementation and maintenance of Owens & Minor Distribution Quality Metrics.
  • Conduct employee training audits to ensure employees are trained and qualified on all assigned tasks.
  • Optimize key relationships with all levels of management within Operations Quality, Product Supply, and Distribution Network. 5) Performs other duties as assigned.

Education & Experience:

  • Bachelor's degree (B.S.) in Engineering or Science related field required
  • Up to three (3) or more of quality engineering experience in a manufacturing environment preferred
  • American Society for Quality (CQA, CQBA, CQE, CQM/OE) and/or Regulatory Affairs Professionals Society or comparable certification preferred
  • Any combination of education and experience to meet the above requirements will be considered

Skills
:

  • Limited knowledge of quality engineering/quality control principles; basic 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) Confidential VERSION 2 preferred
  • Basic understanding of Title 21 Code of Federal Regulations and other Federal and State regulations applicable to O&M's activities
  • Working knowledge of electronic quality/regulatory software 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

Additional Requirements:
Ability to travel on a limited basis, up to 15%

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.


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