Owens & Minor Associate Quality Engineer in Hanover, Maryland
Establishes and continuously improves the quality system for multiple facilities involved in the distribution, repackaging, and relabeling of medical devices.
ESSENTIAL JOB FUNCTIONS:
1.Utilizes quality methods (such as lean/six sigma) to identify and implement operational improvements.
2.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).
3.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.
4.Provides oversight 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.
5.Conducts validation or qualification tests of new or existing equipment, processes or software in accordance with internal protocols.
6.Manages and improves the Master Validation Plan by designing protocols that involve proper sampling techniques, design of experiments, testing, and statistical rationale.
SUPPLEMENTAL JOB FUNCTIONS:
1. Performs additional duties as directed.
EDUCATION & EXPERIENCE REQUIRED:
- Bachelor's degree in Engineering or Science from a four-year college or university required
- Three to five years of experience in a medical device manufacturing environment preferred
- Solid base in quality engineering/quality control principles; solid understanding of statistics, Minitab and/or other statistical software experience
- Six Sigma Black Belt or Lean certification a plus
- Medical Device experience, knowledge of 21 CFR Part 820, (ISO 13485 a plus) preferred
KNOWLEDGE SKILLS & ABILITIES:
1.Working knowledge of Title 21 Code of Federal Regulations and other Federal and State regulations applicable to O&M's private brand products
2.Working knowledge of Pilgrim software or equivalent quality/regulatory software
3.American Society for Quality and/or Regulatory Affairs Professionals Society, or related professional certifications are preferred
4.Ability to work independently and as part of a team
5.Good verbal and written communication skills; strong interpersonal skills
6.Strong analytical capabilities with demonstrated skill in evaluating reports, identifying issues, noting trends, and reporting to these observations to management
7.Must be able to define problems, collect data, establish facts and draw conclusions
8.Ability to analyze and conclude
9.Ability to motivate and direct the work of teammates in multiple facilities in designated areas of responsibility
10.Effective project manager with ability to handle multiple tasks simultaneously prioritizing appropriately
1.Ability to travel on a limited basis, up to 50%