Supplier QA Engineer II

Recruiter: Spencer Gregory Hale

 

Supplier Quality Engineer II

 

About the role:

The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. As a Supplier Quality Engineer II, you play a critical role in ensuring the safety, reliability, and compliance of sourced software used as a medical device (SaMD) or in medical devices (SiMD). You collaborate with suppliers, internal teams, and regulatory bodies to maintain high-quality standards throughout the product lifecycle to consistently meet Boston Scientific’s requirements.

Additionally, the Supplier Quality Engineer II will support sourcing and quality systems by participating in global communities of practice and value improvement projects. The Supplier Quality Engineering team is looking for high energy, driven, passionate people, looking to not just change jobs, but start an amazing career!

 

Your responsibilities include:

1. Supplier Management:
   • Evaluate and select suppliers based on their capabilities, quality systems, and adherence to industry standards.
   • Establish strong relationships with suppliers, fostering open communication and collaboration.
   • Assess supplier capabilities through direct on-site visits and technical discussions. Coordinate the evaluation of proposed changes at suppliers.
   • Evaluate and communicate quality issues to suppliers and apply sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Review and approve supplier corrective action plans and verification of effectiveness documentation.
2. Quality System Champion:
   • Collaborate with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
   • Identify and advise management on potential improvements to quality systems and processes in the company.
   • Champion 100% compliance to company policies and SOP’s.
3. Cross-Functional Collaboration:
   • Work closely with software development teams, quality assurance, regulatory affairs, and other stakeholders.
   • Participate in design reviews, risk assessments, and project meetings.
4. Continuous Improvement:
   • Drive continuous improvement initiatives within global supply chain.
   • Analyze data, track key performance indicators, and identify areas for enhancement.
   • Implement corrective and preventive actions to address quality gaps.

 

What we’re looking for:

Basic Qualifications

• Bachelor’s degree in engineering or a related technical field
• Minimum of 2 years of experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing.
• Experience in software quality assurance, supplier management, or regulatory compliance within the medical device industry.

Preferred Qualifications

• Certification in quality management (e.g., ASQ Certified Quality Engineer) is advantageous.
• Proficiency in relevant standards (e.g., ISO 13485, IEC 62304, FDA regulations).
• Strong analytical skills, attention to detail, and problem-solving abilities.
• Excellent communication and interpersonal skills.
• Domestic and international travel up to 20%

 

 Requisition ID: 584296

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.