Sr. Supplier Quality Engineer

• Compensation: USD 98,000 - USD 123,000 - yearly

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.

Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres Y-90 resin microspheres, is a targeted radiation therapy for liver cancer.

To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement.

At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

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 to 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.

Key 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.

• 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.

Preferred Qualifications

• 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.

The target base salary range for this position will range from $98,000 to $123,000 annually. Individual compensation for this job requisition will be based on non-discriminatory factors, including your geographic location, skills, experience,…