Supplier Quality Assurance Engineer I

Work mode: Hybrid

Onsite Location(s): Arden Hills

About the role:

The External Operations organization at Boston Scientific is a passionate global team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. As a Supplier Quality Engineer I, you play a critical role in ensuring the safety, reliability, and compliance of sourced finished medical devices (SFMD). 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 I will play an integral role in supporting the Cybersecurity Quality Master Plan (QMP) program by developing policies and procedures that address the dynamic and evolving regulatory requirements for cybersecurity. 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 compliance with industry standards.
• Cultivate strong relationships with suppliers by promoting 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, applying systematic problem-solving methodologies to identify, prioritize, and resolve these issues. Review and approve supplier corrective action plans and verify their effectiveness.

2. Quality System Champion:

• Work with supplier quality teams to develop and implement policies, procedures, and guidelines.
• Suggest improvements to company quality systems and processes.
• Ensure full compliance with company policies and SOPs.

3. Cross-Functional Collaboration:

• Collaborate effectively with design and development teams, quality assurance, regulatory affairs, and other pertinent stakeholders.
• Engage in design reviews, conduct risk assessments, and attend project meetings.

4. Continuous Improvement:

• Lead global supply chain improvement efforts.
• Analyze data, monitor KPIs, and pinpoint enhancement opportunities.
• Address quality gaps with corrective and preventive actions.

What we're looking for:

Basic Qualifications:

• Bachelors degree in Mechanical Engineering
• 0-2 years experience in a supplier engineering internship role
• Domestic and international travel up to 10%
• Experience with technical documentation
• Must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization.

Preferred Qualifications:

• Experience with data analysis and reporting
• Experience with or lead auditor certification to ISO13485, 9001, TS16949 standards.
• Experience with auditing supplier quality systems
• Experience in working with mechanical, electrical or software suppliers
• Internship experience with Boston Scientific.