Supplier Quality Engineer III - CE Electronics
$78,300–$78,300 year
On-siteArden Hills, Minnesota, United States
Job Summary
Lead supplier audits, drive corrective actions for manufacturing yield and field failures, and develop acceptance criteria for sourced components. Proactively assess supplier capabilities through on-site visits, evaluate proposed changes, and review approved corrective action plans. Act as a technical lead on Global Sourcing category teams, executing objectives and delivering improvements to quality systems. Independently determine innovative approaches to solutions, interpret Quality Management System modifications, and provide mentorship to junior engineers. Cultivate business relationships with suppliers and middle management to influence strategic business solutions while maintaining full compliance with regulatory and Boston Scientific requirements.
Required Qualifications
- Bachelor's degree in Electrical, Mechanical, Chemical Engineering, or a related technical field
- 3+ years of relevant experience
- Ability to influence cross-functional, global teams including Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing
- Experience with global supplier management and quality management systems, including ISO 13485 and ISO 9001
- Working knowledge of FDA 21 CFR 820
- Ability to operate effectively in a matrixed organization
- Willingness to travel up to 10%
Desired Qualifications
- Electrical, Mechanical, Chemical, or Materials Engineering background
- Advanced degree in Electrical, Mechanical, Chemical, or Materials Engineering
- Strong troubleshooting and root cause analysis skills, with the ability to quickly assess complex quality issues and drive effective corrective and preventive actions
- Proven ability to prioritize and re-prioritize work effectively while managing multiple quality issues, projects, and competing demands in a fast-paced environment
- Experience working cross-functionally with Manufacturing, Engineering, Supply Chain, and Operations
- Strong written and verbal communication skills, with the ability to clearly communicate technical issues and risk to both technical and non-technical audiences
- Experience auditing quality systems or working to ISO 13485, ISO 9001, or TS 16949 standards
- Proficiency with common quality tools and systems (e.g., eQMS, CAPA systems, Excel, Minitab)
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