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.