Beacon Hill is working with an innovative mid-sized medical device company that is looking to grow our their quality department.

Responsibilities -

• 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.
• Assist in the design and development of new products by contributing to risk analysis, verification and validation test plans, etc.
• 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.

Qualifications -

• Bachelor’s Degree in Mechanical, Biomedical engineering or equivalent experience.
• 5+ years of engineering experience in the medical device industry.
• Good understanding of statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA, Design of Experiments (DOE), Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D
• Familiar with FDA Regulations including FDA 21CFR820, ISO13485, ISO 14791, ISO 9001.
• CQE/CQA certification preferred.
• Certified biomedical auditor is preferred.
• Familiar with CAPA, QFDA 21CFR820, ISO13485, ISO 14791, ISO 9001.
• Experience with aseptic production and/or sterilization is preferred.
• Lean and 6Sigma knowledge a plus.