Sr. Quality Systems Engineer

Company Description

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.

Job Description

POSITION SUMMARY 

The Senior Quality Systems Engineer is responsible for maintaining, improving, and ensuring compliance of the Quality Management System (QMS) in alignment with applicable medical device regulations (e.g., FDA QMSR/21 CFR Part 820, ISO 13485, MDSAP). This role operates independently, leads cross-functional quality initiatives, and drives continuous improvement across quality systems processes, including CAPA, Nonconformance (NCR), audits, and Management Review. The position also serves as a key administrator and subject matter expert for the electronic QMS (eQMS).

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 

• Maintain and administer the Quality Management System in full conformance with applicable regulatory standards, including 21 CFR Part 820, ISO 13485 MDSAP, EUMDR, and QMSR.

• Proactively identify systemic gaps, develop improvement initiatives, and drive implementation through cross-functional collaboration. 

• Serve as an internal authority on quality system requirements, providing guidance and interpretation to functional teams. 

• Administer and maintain the electronic Quality Management System (eQMS), including configuration, user management, workflow design, and ongoing optimization. 

• Ensure eQMS system validation status is maintained; coordinate system updates and manage associated change control activities. 

• Develop, maintain, and analyze quality system metrics and key performance indicators (KPIs) to identify trends, assess system performance, and support data-driven decision-making. 

• Prepare and present quality data summaries and trend analyses for leadership and regulatory audiences. 

• Provide guidance for the end-to-end Corrective and Preventive Action (CAPA) and Nonconformance Report (NCR) processes, ensuring timely initiation, appropriate containment, robust root cause analysis, risk-based corrective actions, and documented verification of effectiveness. 

• Provide technical guidance to cross-functional teams in problem-solving methodologies and documentation requirements. 

• Plan, coordinate, and execute the internal audit program, including scheduling, conducting audits, and managing findings through closure. 

• Support external regulatory inspections and notified body audits; coordinate audit logistics and manage response activities. 

• Responsible for providing quality system inputs and documentation and tracking outputs and action items for the Management Review process. 

• Ensure Management Review activities meet regulatory requirements and are completed on a defined schedule. 

• Lead cross-functional initiatives to enhance QMS effectiveness, efficiency, and scalability. 

• Drive a culture of quality and compliance throughout the organization. 

Qualifications

• Bachelor’s degree or higher in Engineering, Life Sciences, or a related technical field required

• 5+ years of experience in Quality Systems within the medical device, pharmaceutical, or biotech industries required

• Proven experience ad