Senior Quality Engineer

At Microline, we are on a mission to improve the quality of life for everyone. To do that, we seek the best talent to expand and improve our team of dedicated, innovative employees.

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

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.

  • Assist in the design and development of new products by contributing to risk analysis, verification and validation test plans, etc.
  • Make effective use of statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA and DOE to solve quality problems and mitigate product and process risks.
  • Make use of Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D and other problem solving techniques.
  • 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
  • Travel for supplier and R&D support
  • Mentor other members of the quality assurance team in statistical and problem solving techniques.
  • Execute cross functional projects using project management methodologies such as critical path methodology, critical chain.
  • Identify and prioritize continual improvement ideas.

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.


  • Bachelor’s Degree in Mechanical or Biomedical engineering or equivalent experience;
  • advanced degree is preferred
  • Very good written and verbal communication skills.
  • ·At least 8 years of engineering experience; preferably in the medical device industry.
  • Experience leading continual improvement projects.
  • 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.·
  • Project management training or certification is a plus.
  • Lean and 6Sigma knowledge a plus.

REASONABLE ACCOMMODATION: Microline is committed to the spirit and letter of the Americans with Disabilities Act and, as required by law, will reasonably accommodate otherwise qualified individuals.

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