Staff Quality Assurance-Supplier Quality Engineer

Posted 3 Days Ago
Be an Early Applicant
Chaska, MN, USA
In-Office
140K-160K Annually
Senior level
Healthtech
The Role
Serve as the single Quality lead for supplier transitions and cost‑reduction/design change programs. Qualify suppliers and components, ensure ISO 13485 and company quality-system compliance, apply risk management, CAPA, and statistical methods, collaborate with sourcing/R&D/operations, approve quality documentation, and drive on‑time, audit‑ready integration of changes into manufacturing.
Summary Generated by Built In

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.

#LI-LCS

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.


For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.


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 [email protected].

Skills Required

  • Bachelor's degree in a technical field with 14+ years experience, or Master's degree with 12+ years, 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
  • Knowledge of ISO 13485 and applicable medical device quality system requirements
  • Ability to create, maintain, and approve risk analyses, supplier qualification records, and change control documentation (audit‑ready)
  • Excellent communication skills and ability to influence suppliers and internal stakeholders
  • Willingness to travel up to 15%
  • 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 impacting performance, cost, manufacturability, or compliance

Danaher Corporation Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Danaher Corporation and has not been reviewed or approved by Danaher Corporation.

  • Healthcare Strength Healthcare coverage is described as comprehensive, including medical plan options alongside dental, vision, life, disability, and mental health support. Wellness initiatives and support programs such as an EAP and vaccination or fitness offerings add breadth beyond core insurance.
  • Retirement Support Retirement benefits include a 401(k) plan with employer matching and options such as pre-tax and Roth contributions. Broader financial rewards such as performance bonuses and access to equity or an employee stock purchase plan are also described.
  • Parental & Family Support Parental leave and family-building support are described as available, including maternity and paternity leave and fertility assistance. Childcare and eldercare support are also highlighted as part of the overall package.

Danaher Corporation Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Washington , DC
57,802 Employees
Year Founded: 1984

What We Do

Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. A global network of more than 25 operating companies, we drive meaningful innovation in some of today’s most dynamic industries through our operating companies in four strategic platforms: Life Sciences, Diagnostics, Water Quality and Product Identification. The engine at the heart of our success is the Danaher Business System (DBS), a set of tools that enables continuous improvement around lean, growth and leadership. Through the ingenuity of our people, the power of DBS and the impact of our meaningful technologies, we help realize life’s potential in ourselves and for those we serve.

Similar Jobs

Cargill Logo Cargill

Senior Software Engineer

Food • Greentech • Logistics • Sharing Economy • Transportation • Agriculture • Industrial
In-Office
Wayzata, MN, USA
155000 Employees
115K-155K Annually

Cargill Logo Cargill

Senior Software Engineer

Food • Greentech • Logistics • Sharing Economy • Transportation • Agriculture • Industrial
In-Office
Wayzata, MN, USA
155000 Employees
115K-155K Annually

Optum Logo Optum

Home Infusion Registered Nurse - Part-Time

Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
In-Office
Roseville, MN, USA
160000 Employees
29-52 Hourly

Optum Logo Optum

Senior Product Manager

Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
In-Office or Remote
Eden Prairie, MN, USA
160000 Employees
113K-193K Annually

Similar Companies Hiring

Sailor Health Thumbnail
Healthtech • Social Impact • Telehealth
New York City, NY
20 Employees
Granted Thumbnail
Artificial Intelligence • Healthtech • Insurance • Mobile • Financial Services
New York, New York
23 Employees
OneImaging Thumbnail
Healthtech
Miami, FL
62 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account