Quality Engineer at Owens & Minor

Toano, Virginia, United States

$60,200 – $111,800Compensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Bachelor’s degree (B.S.) in Engineering or Science required
Three (3) or more years of quality engineering experience in a manufacturing environment required
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
American Society for Quality (CQA, CQBA, CQE, CQM/OE) and/or Regulatory Affairs Professionals Society or comparable certification preferred
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 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
Or any combination of education and experience to meet the above requirements

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) and Work 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 as applicable
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
Establishes, supports, and continuously improves 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