Staff Quality Assurance-Supplier Quality Engineer
$140,000–$160,000 year
On-siteChaska, Minnesota, United States
Job Summary
Serve as the single Quality lead for Value Analysis/Value Engineering (VAVE) programs across North America sites, overseeing instrument system cost-reduction initiatives, end-of-life design changes, and supplier-initiated modifications from concept through manufacturing integration. Own Quality accountability for supplier selection, component qualification, and design changes, collaborating cross-functionally with Sourcing, Procurement, R&D, and Operations to ensure rigorous Purchasing Controls are applied. Act as the primary Quality authority for all design and supplier modifications, driving decisions and approvals that comply with ISO 13485 and Beckman Coulter quality system requirements. Create and approve required quality documentation, including risk analyses and change control records, ensuring audit-ready support for seamless component transfers. This on-site role in Chaska, MN, reports to the Sr. Supplier Quality Manager with up to 15% travel.
Required Qualifications
- Bachelor's degree in technical field
- Master's degree in field
- 14+ years experience (with Bachelor's degree)
- 12+ years experience (with Master's degree)
- 7-10 years' experience in quality engineering or supplier quality within manufacturing environments
- Strong knowledge of quality systems
- Strong knowledge of risk management
- Strong knowledge of CAPA
- Strong knowledge of statistical methods
- Excellent communication skills
- 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
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