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Associate Quality Engineer in Louisville, KY at Owens & Minor, Inc.

Date Posted: 5/20/2019

Job Snapshot

Job Description

POSITION SUMMARY

 

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.



ESSENTIAL JOB FUNCTIONS: 

1.       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).

2.       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.

3.       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. 

4.       Conducts validation or qualification tests of new or existing equipment, processes or software in accordance with internal protocols as applicable.

5.       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.

SUPPLEMENTAL JOB FUNCTIONS:  

1.       Performs additional duties as directed.



Qualifications

EDUCATION & EXPERIENCE REQUIRED:  

  • Bachelor's degree in Engineering or Science required
  • Three 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
  • Or any combination of education and experience to meet the above requirements  

KNOWLEDGE SKILLS & ABILITIES:

  • 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
  • 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 to these 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


ADDITIONAL REQUIREMENTS:  

1.       Ability to travel on a limited basis, up to 10%

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