Medical Device QA Engineer (Supplier Quality | Manufacturing | Compliance)

Medical Device QA Engineer (Supplier Quality | Manufacturing | Compliance)

Location - Minneapolis (Arden Hills and Maple Grove)

Job Type : Contract

Seeking Supplier Quality Engineers with 3+ years' experience in medical devices or regulated industries. Role involves supplier audits, CAPA / SCAR, process validation, sustaining engineering, and new product development support. Engineering degree required.

About the role :

The Supplier Quality Engineer II will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal / external resources to continually improve our supplier's manufacturing processes. In this role, you will support SFMD products within the Relievant acquisition in the Neuromodulation division with a primary focus on Single-Use Devices and Capital Equipment accessories.

Your responsibilities include :

Sustaining Engineering :

• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
• Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Manages sustaining quality issues, process change impacts, and design change implementations for suppliers within the Relievant Quality system, the hybridized BSC-Relievant Quality System, and in the BSC Quality System after products are successfully integrated.
• Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
• Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
• Investigates complaints and manages NCEPs at OEM suppliers and CM suppliers where the issue is manufacturing-related.
• Supports Supplier Change Impact Assessments for process changes at suppliers.
• Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
• Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process.

New Product Development :

Required Qualifications :

Preferred Qualifications :