Associate Quality Engineer
Company: Owens & Minor
Posted on: August 6, 2022
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
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
- 401(k), eligibility after 30 days of employment
- Employee stock purchase plan
- Tuition reimbursement
- Development opportunities to grow your career with a global
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.
- 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
- 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).
- Bachelor's degree (B.S.) in Engineering or Science related
- 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
- 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
- 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
- Working knowledge of electronic quality/regulatory software a
- 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
Keywords: Owens & Minor, Ontario , Associate Quality Engineer, Engineering , Ontario, California
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