Staff Quality Assurance-Supplier Quality Engineer

About the role

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.

Responsibilities

• 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.
• Ensure 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.

Requirements

• 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%
• Previous 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

Qualifications

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.

Benefits

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.

Pay

No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.

Schedule

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 applyassistance@danaher.com.