Job Description

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.

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.

Qualifications

• 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, education and other factors as they relate to the position requirements. Actual compensation may vary depending on the confirmed job-related skills and experience.

In addition to the expected base compensation, this role is eligible to participate in Sirtex's incentive programs (target bonus of 5% for this position) and benefit plans, which include paid sick and vacation time, health insurance and a generous 401k matching program

Additional Information

Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people's lives. Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success.

Sirtex offers qualified candidates:

• Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
• A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
• Attractive compensation and benefit packages which are practical, robust and equitable.
• A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
• Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
• An unwavering commitment to company values, employee safety and excellence in everything we do.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.