Senior Quality Engineer

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

Benefits offered by this job

Bonus eligibility

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Senior Quality Engineer to join the Instrument Quality team in Chaska, MN. You will ensure compliance with the Quality Management System and regulations, leading reviews of documents and processes to prevent defects and nonconformances.

On-site role offering exposure to design controls, risk management, and Kaizen-driven lean improvements in a regulated medical device environment. Salary range $90-110k plus bonus eligibility.

Qualifications

• Engineering degree in a relevant field with 5+ years of experience.
• Experience applying Design Controls and 21 CFR 820 to moderately complex design changes.
• Experience applying Risk Management ISO14971 for Medical Device companies.

Responsibilities

• Conduct comprehensive reviews of manufacturing SOPs, change orders, bill of materials, service manuals, part drawings, material specification sheets, field service manuals, nonconformance records, CAPAs and other quality records to ensure compliance with the Quality System and regulations.
• Lead Kaizen events to improve transactional processes, reduce variation, and implement lean processes on the production floor to reduce cycle time and waste.
• Reduce instrument defects by evaluating issues identified and implementing countermeasures to prevent recurrence.
• Reduce nonconformances by evaluating issues identified and implementing countermeasures to prevent recurrence.
• Assess risk associated with design changes, internal product non-conformances, external post-launch issues, and systemic issues of the Quality system or instrument manufacturing business.

Skills

Design Controls

Risk Management

Quality Engineering

Lean / Kaizen

Education

Bachelor's degree in Mechanical / Electrical / Chemical engineering

Master's degree in relevant field

Doctoral degree in field

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

Learn about the Danaher Business System which makes everything possible.

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.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].