Senior Supplier Quality Engineer - SFMD
$85,000–$85,000 year
On-siteMaple Grove, Minnesota, United States
Job Summary
Evaluate and communicate quality issues to suppliers, applying systematic problem-solving methodologies to identify, prioritize, and resolve defects. Review and approve corrective action plans while coordinating on-site visits and technical discussions to assess supplier capabilities. Plan and lead audits to ensure compliance with regulatory and Boston Scientific requirements, managing investigation, reporting, and follow-up actions. Lead execution of quality deliverables for new product development, generating and reviewing quality plans, agreements, and design validations. Collaborate with cross-functional teams to develop policies, procedures, and guidelines, advising management on process improvements. Maintain 100% compliance with company policies and SOPs. Domestic and international travel up to 25%.
Required Qualifications
- BS degree in engineering or technical field
- 5 years relevant experience
- Experience in the medical device, automotive, aeronautical, semiconductor, or other regulated industry
- Project management: the ability to influence cross-functional global teams spanning quality, operations, R&D, and sourcing
- Experience in process validation, design controls, risk management, and CAPA
- Ability to work independently; organized and self-driven
- Articulate communicator; adept at packaging and appropriately scaling information to the intended audience
- Ability to rapidly learn and use new software applications (e.g., PLM, ERP)
- Domestic and international travel up to 25%
- Prohibited substance test
Desired Qualifications
- 7+ years of medical device engineering experience
- Ability to speak Spanish in a professional setting
- Leadership experience on a materials or service commodity team
- Lead auditor of quality systems experience (ISO 13485 or similar)
- ASQ certification (CQE, CBA, SSGB, SSBB)
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