Senior Quality Engineer, Medical Devices & Compliance

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

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Senior Quality Engineer to ensure the Quality Management System compliance and regulatory alignment. This on-site role is based in Chaska, MN within the Instrument Quality organization and reports to the Quality manager.

You will review SOPs, change controls, BOMs, service manuals, and quality records; lead Lean initiatives; manage risk for design changes and post-launch issues; and drive corrective actions to prevent recurrence.

Qualifications

• Experience applying Design Controls and Design Changes according to 21CFR820 to moderately complex design changes.
• Experience applying Risk Management ISO14971 for Medical Device companies.
• Certified Quality Engineering certification is a plus.

Responsibilities

• Conduct comprehensive reviews of manufacturing SOPs, change orders, BOMs, service manuals, drawings, specifications, field service manuals and quality records to ensure Quality System compliance.
• Lead Kaizen events to improve transactional processes and implement lean on the production floor to reduce cycle time and wastes.
• Reduce instrument defects by evaluating issues and implementing countermeasures to prevent recurrence.
• Assess risk associated with design changes, internal non-conformances, external post-launch issues and systemic quality system issues.

Skills

Design Controls

Risk Management ISO14971

Certified Quality Engineer

Education

Bachelor's degree in field

Master's degree in field

Doctoral degree in field

Job description

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Senior Quality Engineer to ensure the Quality Management System compliance and regulatory alignment. This on-site role is based in Chaska, MN within the Instrument Quality organization and reports to the Quality manager.

You will review SOPs, change controls, BOMs, service manuals, and quality records; lead Lean initiatives; manage risk for design changes and post-launch issues; and drive corrective actions to prevent recurrence.