Senior Quality Engineer - Diagnostics & Life Sciences

Beckman Coulter Diagnostics; Chaska (MN); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Bonus eligibility

Healthcare & 401(k) benefits

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Senior Quality Engineer in Chaska, MN to ensure compliance with the Quality Management System and regulatory requirements. You will lead design controls, risk management, and investigations to uphold instrument quality across the portfolio.

You will be on-site with the Instrument Quality organization and report to the Quality Manager. Collaboration with cross-functional teams will drive continuous improvement and reduce

Qualifications

• Engineering degree in relevant field
• Experience with Design Controls and Design Changes per 21CFR820
• Experience with ISO14971Risk Management in Medical Devices

Responsibilities

• Conduct comprehensive reviews of quality records and change controls to ensure regulatory compliance.
• Lead Kaizen events and lean initiatives on the production floor to reduce cycle times and waste.
• Assess risk for design changes, non-conformances, post-launch issues, and systemic Quality System issues.

Job description

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Senior Quality Engineer in Chaska, MN to ensure compliance with the Quality Management System and regulatory requirements. You will lead design controls, risk management, and investigations to uphold instrument quality across the portfolio.

You will be on-site with the Instrument Quality organization and report to the Quality Manager. Collaboration with cross-functional teams will drive continuous improvement and reduce