Associate Quality Engineer

Company: Owens & Minor
Location: Ontario
Posted on: August 6, 2022

Job Description:

At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 50+ facilities across the US and 18,000 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 30 days of employment
• Employee stock purchase plan
• Tuition reimbursement
• Development opportunities to grow your career with a global company
  Job Summary
  Associate Quality Engineer supports, and continuously improves the operations and quality system elements for the facility involved in the distribution, repackaging and relabeling of medical devices. Serves as a quality contact for assigned areas of oversight and accountable for all quality outputs for those respective areas. Supports reduction of defects and problem resolution utilizing a variety of investigative and analytical tools. The individual will contribute to achieving the milestones and objectives for their assigned areas of responsibility.
  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, and relabeling of medical devices.
  • Supports operations to define quality objectives for key performance indicators (KPIs). Supports the implementation of associated measurement systems and collects, monitors data for relevant trends of KPIs.
  • Supports oversight of associated 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 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 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
    • 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) 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
    • 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
    • Ability to travel on a limited basis, up to 25%
      If you feel this opportunity could be the next step in your career, we encourage you to apply.
      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.

Keywords: Owens & Minor, Ontario , Associate Quality Engineer, Engineering , Ontario, California