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
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.
- 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.
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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