Sr. Quality Systems Engineer

Sirtex Medical; Woburn (MA); Hybrid; USD 94,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Generous 401(k) matching program

Paid sick and vacation time

Diverse and flexible work arrangements

Job summary

Sirtex Medical is looking for a QMS Manager in Woburn, Massachusetts to maintain the Quality Management System and ensure compliance with regulatory standards. You'll collaborate cross‑functionally to drive improvement initiatives and present quality data to leadership.

The ideal candidate holds a Bachelor's degree and has over 5 years of experience in quality systems within the medical device or biotech industries. A strong compliance mindset and problem-solving capability are essential for ensuring audit-ready documentation.

Qualifications

• 5+ years in Quality Systems within medical device, pharmaceutical, or biotech industries.
• Experience optimizing eQMS platforms, including workflow configuration.
• Strong knowledge of FDA QMSR, ISO 13485, and global regulatory requirements.

Responsibilities

• Maintain and administer the Quality Management System.
• Drive improvement initiatives through cross‑functional collaboration.
• Plan and execute the internal audit program.

Skills

Quality Management Systems

Regulatory Standards Compliance

Data Analysis

Project Management

Problem-Solving

Education

Bachelor's degree in Engineering, Life Sciences, or a related field

Tools

Veeva Vault

MasterControl

Power BI

Tableau

Job description

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 manageresponse 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.
• 5+ years of experience in Quality Systems within the medical device, pharmaceutical, or biotech industries.
• Proven experience administering and optimizing eQMS platforms (e.g., Veeva Vault, MasterControl, ETQ, TrackWise), including workflow configuration and governance.
• Strong analytical capability with experience developing metrics, trending quality data, and driving data‑based decision making.
• Strong working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, MDSAP, and global regulatory requirements.
• Ability to work independently, prioritize effectively, and lead complex projects, implementation, and continuous improvement of QMS processes and SOPs.
• Strong problem‑solving and root‑cause analysis skills (e.g., using tools such as 5 Whys, Fishbone, FMEA).
• Excellent written and verbal communication skills with the ability to present to executive leadership and external auditors.
• Detail‑oriented with a strong compliance mindset and ability to ensure audit‑ready documentation.
• Candidates must be located in the Boston, MA area and be able to adhere to the hybrid policy of 3 days in office and 2 days remote.

Preferred Qualifications

• Advanced degree (MS, MBA) in a technical or related field.
• ASQ certification (e.g., CQE, CQA) or equivalent professional certification.
• Direct experience with Veeva Vault QualityDocs or similar cloud‑based eQMS platforms.
• Background in data visualization and tools (e.g., Power BI, Tableau, advanced Excel).
• Experience leading QMS transformation, harmonization, or integration efforts (e.g., post‑acquisition environments).
• Familiarity with risk management principles per ISO 14971 and integration with quality system processes.

Salary

The target base salary range for this position will range from $94,000 to $119,000 annually. 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%) and benefit plans, which include paid sick and vacation time, health insurance, and a generous 401(k) matching program.

Benefits

• 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‑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.

EEO Statement

All your information will be kept confidential according to EEO guidelines. Sirtex is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, age, or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.