Job Description

Quality Engineer

Contract Assignment 3+ Months

M-F 40 Hours weekly, Possible Transition to Direct

JOB SUMMARY:  Maintain the quality system and support outgoing product quality through the use of engineering tools and methodologies in order to support production, design, and development of medical devices. 

 

ESSENTIAL FUNCTIONS:  The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.

  • Assist in the design and development of new products by contributing to risk analysis, verification and validation test plans, etc.
  • Good understanding of statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA and DOE.
  • Good problem solving experience with Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D.
  • Approve Engineering Change Orders, review prints and be familiar with Geometric Tolerancing.
  • Maintain Quality Records.
  • Perform Corrective Actions and Non-conformance assessments.
  • Assist in investigating customer complaints.
  • Perform internal audits as well as supplier audits.
  • Support Incoming Inspection.
  • Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems and analysis trends.
  • Participate in and lead continual improvement projects
  • Support environmental and sterilization monitoring
  • Some travel required for supplier support

 

NON-ESSENTIAL FUNCTIONS: 

In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions.  Employees are required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.

 

QUALIFICATIONS:

  • Bachelor’s Degree in Mechanical or Biomedical engineering or equivalent experience.
  • Very good written and verbal communication skills.
  • At least 5 years of engineering experience; preferably in the medical device industry.
  • CQE/CQA certification helpful but not required.
  • Certified biomedical auditor is preferred.
  • Familiar with FDA 21CFR820, ISO13485.
  • Experience with aseptic production and/or sterilization is preferred.
  • Accuracy, thoroughness, attention to detail, legibility in completing records is essential.
  • Lean and 6Sigma knowledge a plus.

 

Application Instructions

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