Senior Quality Engineer - Life Sciences Impact & Lean

Regulatory Jobs; Chaska (MN); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Bonus eligibility

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Senior Quality Engineer to join the Instrument Quality team in Chaska, MN. You will ensure compliance with the Quality Management System and regulations, leading reviews of documents and processes to prevent defects and nonconformances.

On-site role offering exposure to design controls, risk management, and Kaizen-driven lean improvements in a regulated medical device environment. Salary range $90-110k plus bonus eligibility.

Qualifications

• Engineering degree in a relevant field with 5+ years of experience.
• Experience applying Design Controls and 21 CFR 820 to moderately complex design changes.
• Experience applying Risk Management ISO14971 for Medical Device companies.

Responsibilities

• Conduct comprehensive reviews of manufacturing SOPs, change orders, bill of materials, service manuals, part drawings, material specification sheets, field service manuals, nonconformance records, CAPAs and other quality records to ensure compliance with the Quality System and regulations.
• Lead Kaizen events to improve transactional processes, reduce variation, and implement lean processes on the production floor to reduce cycle time and waste.
• Reduce instrument defects by evaluating issues identified and implementing countermeasures to prevent recurrence.
• Reduce nonconformances by evaluating issues identified and implementing countermeasures to prevent recurrence.
• Assess risk associated with design changes, internal product non-conformances, external post-launch issues, and systemic issues of the Quality system or instrument manufacturing business.

Skills

Design Controls

Risk Management

Quality Engineering

Lean / Kaizen

Education

Bachelor's degree in Mechanical / Electrical / Chemical engineering

Master's degree in relevant field

Doctoral degree in field

Job description

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Senior Quality Engineer to join the Instrument Quality team in Chaska, MN. You will ensure compliance with the Quality Management System and regulations, leading reviews of documents and processes to prevent defects and nonconformances.

On-site role offering exposure to design controls, risk management, and Kaizen-driven lean improvements in a regulated medical device environment. Salary range $90-110k plus bonus eligibility.