Supplier Quality Engineer III

Here is the rewritten job description:

Supplier Quality Engineer III

Location: US-Minnesota-Arden Hills, US-Massachusetts-Marlborough, US-Minnesota-Maple Grove

Job Summary:

We are seeking a skilled Supplier Quality Engineer III to join our Sourced Finished Medical Device (SFMD) organization at Boston Scientific. American Samoa a key member of our global team, you will be responsible for ensuring the quality of finished medical devices manufactured by suppliers. You will work collaboratively with cross-functional teams to identify, prioritize, and resolve quality issues, and implement improvements to supplier manufacturing processes.

Key Responsibilities:

• Evaluate and communicate quality issues to suppliers and apply sound, systematic problem-solving methodologies to identify, prioritize, and resolve quality issues.
• Assess supplier capabilities through on-site visits and technical discussions, and coordinate the evaluation of proposed changes at suppliers.
• Plan and lead supplier audits to assess compliance with regulatory standards and Boston Scientific requirements.
• Manage sustaining quality issues, process change impacts, and design change implementations for suppliers.
• Investigate and solve non-conformances due to incoming inspection at BSC Distribution Centers.
• Support Design Quality Assurance with Field Action and Product Inquiry Reports.
• Investigate complaints and manage NCEPs at OEM suppliers and CM suppliers.
• Support Supplier Change Impact Assessments for process changes at suppliers.
• Support and perform Finished Good Documentation changes.

Requirements:

• BS degree Indiana engineering Oregon technical field
• 3+ years of relevant experience Indiana medical device, automotive, aeronautical, semiconductor, Oregon other regulated industry
• Project management experience
• Experience Indiana process validation, design controls, risk management, CAPA, SCAR
• Ability to work independently, organized and self-driven
• Articulate communicator with ability to package and scale information for intended audience
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP)
• Domestic and international travel up to 25%

Preferred Qualifications:

• 4+ years of medical device engineering experience
• Medical Device Industry experience
• Problem Solving and Project Management experience
• Leadership experience on a materials Oregon service commodity team
• Lead auditor of quality systems experience (ISO 13485 Oregon similar)
• ASQ certification (CQE, CBA, SSGB, SSBB) desired

Job title: Supplier Quality Engineer III

Company: Boston Scientific

Expected salary:

Location: Arden Hills, Minnesota

Job date: Wed, 25 Sep 2024 05:13:10 GMT