Staff Quality Assurance-Supplier Quality Engineer

Beckman-Coulter-Diagnostics; Chaska (MN); On-site; USD 140,000 - 160,000; Full time

Benefits offered by this job

Bonus eligible

Medical/dental/vision insurance

401(k) plan

Job summary

Beckman Coulter Diagnostics in Minnesota seeks a Staff Quality Assurance-Supplier Quality Engineer to lead supplier transitions and cost-saving design changes, ensuring on-time manufacturing integration and zero downstream quality issues.

You will drive quality decisions across supplier selection, component qualification, and change control, ensuring compliance with ISO 13485 and Beckman Coulter quality system requirements. This on-site role in Chaska, MN requires travel up to 15%.

Qualifications

• Bachelor’s degree in a technical field with 14+ years experience or Master’s degree with 12+ years experience.
• Minimum 7-10 years’ experience in quality engineering or supplier quality within manufacturing environments.
• Strong knowledge of quality systems, risk management, CAPA and statistical methods.
• Excellent communication skills and ability to influence both suppliers and internal stakeholders.
• Willingness to travel up to 15%.

Responsibilities

• Serve as the single Quality lead for Value Analysis/Value Engineering (VAVE) programs across North America sites, driving cost-savings and quality approvals.
• Own Quality accountability for supplier selection, approval and component qualification; collaborate with Strategic Sourcing, Procurement, R&D, and Operations.
• Act as primary Quality authority for all design and supplier modifications; ensure compliance with ISO 13485 and Beckman Coulter quality systems.
• Ensure that cost-reduction, design evolution, and supplier transition activities meet Purchasing Controls, Design Controls, Document Controls, and Risk Management expectations; obtain final Quality approval.
• Create, maintain, and approve risk analyses, supplier qualification records, change control documentation, and support files.

Skills

Quality engineering

Supplier quality

Quality systems

Risk management

CAPA

Statistical methods

Communication skills

Travel up to 15%

Education

Bachelor’s degree in technical field

Master’s degree in field

Tools

CQE

CQA

Six Sigma

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 Staff Quality Assurance-Supplier Quality Engineer is responsible for serving as the single Quality member for supplier transitions, and design changes related to cost savings initiatives that directly influence product cost, reliability, and supply continuity. This role drives measurable organizational impact by ensuring new suppliers, components, and product improvements are qualified, verified, and integrated into manufacturing on time, within scope, and without downstream quality issues. This position reports to the Sr. Supplier Quality Manager and is part of the Supplier Quality located in Chaska, MN and will be an on-site role.

Remote option will be considered for qualified candidates who are not local.

In this role, you will have the opportunity to:

• Serve as the single Quality lead for Value Analysis/Value Engineering (VAVE) programs from our North America sites —including instrument system cost‑reduction initiatives, EOL‑driven design changes, supplier‑initiated changes, and quality‑based product improvements—ensuring full quality oversight from concept through manufacturing integration and measured by on‑time delivery to project milestones, cost‑savings realization, and fact‑based Quality approvals enabling smooth manufacturing integration.
• Own Quality accountability for supplier selection, approval and component qualification, collaborating cross‑functionally with Strategic Sourcing, Procurement, R&D, and Operations to assess supplier capability, qualify new components, and ensure rigorous Purchasing Controls are applied throughout the change process.
• Act as primary Quality authority for all design and supplier modifications, ensuring projects comply with ISO 13485 and all applicable Beckman Coulter quality system requirements; drive quality decisions and approvals for advancement at each project phase.
• Ensure that cost‑reduction, design evolution, and supplier transition activities fully meet Purchasing Controls, Design Controls, Document Controls, and Risk Management expectations, with owning final Quality approval for readiness to advance and indicated by absence of post‑implementation quality issues.
• Create, maintain, and approve required quality documentation—including risk analyses, supplier qualification records, change control documentation, and support files— measured by clear, audit‑ready documentation supporting seamless transfer of updated components or designs into manufacturing.

The essential requirements of the job include:

• Bachelor’s degree in technical field with 14+ years experience or Master’s degree in field with 12+ years experience or comparable
• Minimum 7-10 years’ experience in quality engineering or supplier quality within manufacturing environments.
• Strong knowledge of quality systems, risk management, CAPA and statistical methods.
• Excellent communication skills and ability to influence both suppliers and internal stakeholders.
• Willingness to travel up to 15%

It would be a plus if you also possess previous experience in:

• Experience in FDA-regulated or medical device manufacturing environments.
• Certifications such as CQE, CQA, Six Sigma, or equivalent.
• Demonstrated ability to evaluate and qualify supplier or design changes that impact performance, cost, manufacturability, or compliance.

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 $140,000 to $160,000. 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.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

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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].