Our client, a provider of surgical precision instruments, has an immediate opening for a Quality Engineer. This role will 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.

Responsibilities:

• Assist in the design and development of new products by contributing to risk analysis, verification, and validation test plans
• 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
• Other responsibilities as required

Requirements:

• Bachelor’s Degree in mechanical or biomedical engineering or equivalent experience
• At least 5 years of engineering experience, preferably in the medical device industry
• Familiar with FDA 21CFR820, ISO13485
• Accuracy, thoroughness, attention-to-detail, and legibility in completing records
• Very good written and verbal communication skills
• 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
• CQE/CQA certification helpful but not required
• Certified biomedical auditor is preferred
• Experience with aseptic production and/or sterilization is preferred
• Lean and 6Sigma knowledge a plus
• Some travel required for supplier support