Senior Quality Engineer

Work Location:

Fully onsite in Arden Hills, MN

* Client cannot provide sponsorship*

Insight Global is seeking a Senior Quality Engineer to support a leading medical device manufacturer specializing in combination medical devices. This newly created role is focused on establishing a best-in-class approach to drug-device combination products, integrating pharmaceutical science, quality systems, and manufacturing execution. This role partners closely with Operations and Product Development teams to ensure compliance with current Good Manufacturing Practices (cGMP) and 21 CFR Part 4 requirements for drug-device combination products manufactured in the Urology business.

The individual will lead quality and continuous improvement initiatives, serve as the technical quality lead during audits, analyze quality data and manufacturing metrics to identify trends and drive corrective actions, and collaborate with cross-functional teams to reduce defects, nonconformances, and customer complaints. Responsibilities also include developing quality plans, specifications, risk assessments, FMEAs, process monitoring systems, training materials, and quality tools;

supporting product containment and release activities; evaluating the effectiveness of quality systems and manufacturing operations; and conducting internal audits to support ongoing compliance and continuous improvement within the client Quality System. This position is fully onsite in Arden Hills, MN, and offers a salary range of $100,000-$125,000 plus a 10% bonus, depending on experience.

• Bachelor's degree in Chemical Engineering, Chemistry or related scientific or engineering discipline
• 5+ years of relevant manufacturing, quality or related regulated industry
• Minimum of 2 years of experience supporting regulated cGMP compliance for drug-device combination products or pharmaceutical manufacturing
• Proven knowledge of statistical analysis methods and proficiency with Excel and Minitab
• Experience supporting internal and external quality audits

• 7+ years of experience in in manufacturing, quality or regulatory functions
• 2+ years of experience in technical leadership
• Experience managing multiple cross functional projects simultaneously
• Recent or current experience serving as a technical lead during external regulatory audits
• Demonstrated commitment to proactive quality, regulatory compliance and continuous improvement