Quality Engineer – Medical Device

JOB SUMMARY: Maintain the quality system and support outgoing product quality through the use of engineering tools and methodologies in order to support the production, design, and development of medical devices.

Responsibilities:

• 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

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, and legibility in completing records is essential.
• Lean and 6Sigma knowledge a plus.

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