Quality Engineer

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.

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.