Staff Quality Assurance-Supplier Quality Engineer

Danaher•Chaska, MN

5d•Hybrid

About The Position

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.

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%

Nice To Haves

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.

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—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.