Job Description

Quality Engineer

Temp to Direct (6+Months) or Direct hire

Work is 100% onsite

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 nonessential 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

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

Apply Online