Senior Quality Engineer, Diagnostics – Onsite MN

Danaher Corporation; Chaska (MN); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Bonus eligible

Comprehensive benefits

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, is hiring a Senior Quality Engineer for the Instrument Quality organization in Chaska, MN. The role focuses on ensuring compliance with the Quality Management System and relevant regulations, with on-site responsibility.

You will review SOPs, change orders, BOMs, manuals, records, and CAPAs, lead Kaizen events, and drive defect reduction and risk assessment across design changes and post-launch issues.

Qualifications

• Engineering degree with 5+ years of experience or higher degrees with corresponding experience.
• Experience applying Design Controls per 21 CFR 820.
• Experience applying ISO14971 risk management for medical devices.

Responsibilities

• Review manufacturing SOPs, change orders, bill of materials, service manuals, part drawings, material specs, field service manuals, nonconformance records, CAPAs to ensure Quality System compliance.
• Lead Kaizen events to improve transactional processes, reduce variation, and implement lean on the production floor.
• Reduce instrument defects by evaluating issues and implementing countermeasures to prevent recurrence.
• Reduce nonconformances by evaluating issues and implementing countermeasures to prevent recurrence.
• Assess risk related to design changes, internal non-conformances, external post-launch issues, and systemic quality issues.

Skills

Design Controls

Risk Management ISO14971

Education

Bachelor’s degree or higher in a relevant field

Job description

Beckman Coulter Diagnostics, a Danaher operating company, is hiring a Senior Quality Engineer for the Instrument Quality organization in Chaska, MN. The role focuses on ensuring compliance with the Quality Management System and relevant regulations, with on-site responsibility.

You will review SOPs, change orders, BOMs, manuals, records, and CAPAs, lead Kaizen events, and drive defect reduction and risk assessment across design changes and post-launch issues.