Senior Quality Engineer

Insight Global; Arden Hills (MN); On-site; USD 100,000 - 125,000; Full time

Benefits offered by this job

On-site work in Arden Hills

Bonus program (10% of salary)

Job summary

Insight Global is seeking a Senior Quality Engineer to support a leading medical device manufacturer specializing in drug-device combination products. This role focuses on establishing a best-in-class approach to quality, integrating pharmaceutical science, quality systems, and manufacturing execution.

The position is fully onsite in Arden Hills, MN, with a salary range of $100,000-$125,000 plus a 10% bonus, and requires a Bachelor's in Chemical Engineering, Chemistry or related field, 5+ years

Qualifications

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

Responsibilities

• Lead quality and continuous improvement initiatives.
• Serve as technical quality lead during audits and regulatory reviews.
• Analyze quality data and manufacturing metrics to identify trends and drive corrective actions.
• Collaborate with cross-functional teams to reduce defects, nonconformances and customer complaints.
• Develop quality plans, risk assessments, FMEAs and process monitoring systems.

Skills

Statistical analysis

Audits

Education

Bachelor's degree in Chemical Engineering, Chemistry or related scientific or engineering discipline

Tools

Excel

Minitab

Job description

Work Location: Fully onsite in Arden Hills, MN

*Client cannot provide sponsorship*

Job Description

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.

Must have skills and experiences:

• 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

Nice to have skills and experiences:

• 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