Sr. Supplier Quality Engineer

Sirtex • Woburn, MA

14h • Hybrid

About The Position

The Senior Supplier Quality Engineer (Sr. SQE) is responsible for ensuring the quality, compliance, and performance of external suppliers and contract manufacturers supporting medical device production. This role operates independently, leads cross-functional supplier quality initiatives, and drives continuous improvement across the supply base. The Sr. SQE ensures alignment with global medical device regulations and company quality standards while mitigating supplier-related risks. NOTE: Candidates must be local the Boston, MA area and be able to adhere to our hybrid policy, which is currently 3 days/week in office and 2 days/week remote.

Requirements

• Bachelor’s degree in Engineering or related technical discipline required.
• 5+ years of experience in supplier quality within the medical device or regulated industry required.
• Proven experience managing contract manufacturers and critical suppliers.
• Strong expertise in supplier auditing and regulatory compliance (ISO 13485, FDA QMSR, MDSAP).
• Demonstrated ability to work independently, lead initiatives, and drive measurable improvements.
• Excellent problem-solving, communication, and stakeholder management skills.

Nice To Haves

• Lead Auditor certification (ISO 13485 or equivalent).
• Experience with global regulatory environments and multi-site supply chains.
• Experience onboarding and managing suppliers providing software development, Software as a Medical Device (SaMD), system solutions, and software sustaining services.

Responsibilities

• Lead qualification, evaluation, and ongoing management of suppliers and contract manufacturers.
• Conduct and lead supplier audits (onsite and remote) to assess compliance with ISO 13485, FDA QMSR, and other applicable regulations.
• Drive supplier corrective and preventive actions (SCAR/CAPA), ensuring timely and effective resolution of quality issues.
• Provide technical oversight of supplier processes, including validation, change control, and process improvements.
• Partner cross-functionally (R&D, Manufacturing, Regulatory, Procurement) to ensure supplier performance meets product and regulatory requirements.
• Monitor supplier KPIs and implement continuous improvement initiatives to enhance quality, delivery, and cost performance.
• Ensure compliance with applicable medical device regulations and standards, including risk management (ISO 14971) and supplier controls.
• Support new product introductions and technology transfers involving external suppliers.

Benefits

• paid sick and vacation time
• health insurance
• 401k matching program
• incentive programs (target bonus of 5% for this position)
• Diverse and flexible work arrangements
• A culture of respect, diversity, collaboration, and innovation
• Attractive compensation and benefit packages
• support ongoing professional growth through career development, on the job experiences and training opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior