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. In this role, you will have the opportunity to: - 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. The essential requirements of the job include: - 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. It would be a plus if you also possess previous experience in: - Certified Quality Engineering certification preferred. Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. The annual salary range for this role is $90-110k. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.