Senior Quality Engineer

Danaher•Chaska, MN

1d•Onsite

About The Position

The Senior Quality Engineer for Beckman Coulter Diagnostics is responsible for ensuring the business is compliant to the Quality Management System and the Regulations. This position is part of the Instrument Quality organization located in Chaska, MN and will be primarily on-site. You will be a part of the Instrument Quality organization and report to the Quality manager responsible for Instrument Quality.

Requirements

Engineering degree in a relevant field (i.e. Mechanical, Electrical, Chemical, etc.)
Bachelor’s degree in field with 5+years exp. OR Master’s degree in field with 3+ years exp. OR Doctoral degree in field with 0-2 years exp
Experience applying Design Controls and Design Changes according to 21CFR820 to moderately complex design changes.
Experience applying Risk Management ISO14971 for Medical Device companies.

Nice To Haves

Certified Quality Engineering certification preferred.

Responsibilities

Conduct comprehensive reviews of the manufacturing SOPs (standard operating procedures), document change orders, bill of materials, service manuals, part drawings, material specification sheets, field service manuals, nonconformance records, CAPAs (corrective and preventive actions) and other quality records to ensure that they are compliant with requirements of the Quality System and the regulations.
Lead Kaizen events aimed at improving the transactional process, reduce process variations, and to implement lean processes in the production floor to reduce cycle time, maximize resource utilization, improve the experience and engagement of the production associates, and eliminate lean wastes such as correction, overproduction, motion, material movement, waiting, inventory, and process.
Reduce instrument defects by investing/evaluating the issues identified and implementing countermeasures to prevent recurrence.
Reduce Nonconformances by investing/evaluating the issues identified and implementing countermeasures to prevent recurrence.
Assess the risk associated with: (i). design changes; (ii). Internal product non-conformances, (iii). External post-launch issues (iv). Systemic issues of the Quality system or instrument manufacturing business.