Staff Quality Assurance-Supplier Quality Engineer

Beckman Coulter Diagnostics is a global leader in clinical diagnostics committed to innovating for tangible impact in life sciences and biotechnology. The Staff Quality Assurance-Supplier Quality Engineer is responsible for ensuring new suppliers and product improvements are qualified and integrated into manufacturing on time, driving organizational impact and quality oversight throughout the process.

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

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%
• 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