Quality Systems Specialist

Your Role

As a Quality Systems Specialist, you will play a critical role in maintaining and improving our ISO 13485-certified Medical Device Quality Management System (MDQMS). You’ll ensure compliance with global medical device regulations and support the smooth operation of quality processes across our design projects. This is a hands-on role focused on document control, internal audits, CAPA management, training administration, calibration tracking, and supplier monitoring - keeping our MDQMS audit-ready at all times.

You will play a key role in:

• Document & Record Control: Managing controlled documents, change control workflows, and ensuring accurate, audit-ready records.
• Document Authoring & Support: Assisting in drafting and updating SOPs under direction, writing Work Instructions, and creating forms/templates to support MDQMS processes.
• Internal Audits: Planning and conducting internal audits, documenting findings, and tracking corrective actions to closure within defined timelines.
• CAPA & Nonconformance Management: Driving root cause analysis, implementing corrective actions, and verifying effectiveness.
• Training Program Administration: Assigning and tracking training for SOP updates, evaluating training effectiveness, escalating overdue items, and maintaining complete training/competence records.
• Calibration & Maintenance Oversight: Maintaining the monitoring and measuring equipment register, scheduling calibrations, managing out-of-tolerance investigations, and ensuring scheduled maintenance for critical equipment is documented and audit-ready.
• Supplier Monitoring: Tracking ISO 13485 certificates for approved suppliers, ensuring timely renewals, performing periodic re‑evaluation and performance monitoring (proportional to risk), and updating supplier status.
• Quality Metrics & Reporting: Preparing monthly quality performance reports aligned to required Management Review inputs (e.g., audits, CAPA status, training effectiveness, supplier status, calibration etc)
• Continuous Improvement: Identifying and implementing process improvements to enhance efficiency and compliance.

Your Profile

• Education: Bachelor’s degree in engineering, life sciences, or a related field (or equivalent experience).
• Experience: 2–5+ years in a medical device environment with hands-on MDQMS experience (ISO 13485).
• Skills & Knowledge:
• Internal auditing and CAPA management.
• Document control and change management.
• Training system administration and compliance tracking.
• Familiarity with calibration processes and supplier quality monitoring.
• Strong technical writing and organizational skills.
• Certifications: ISO 13485 Internal Auditor (or willingness to obtain within 3 months).
• Nice-to-Have: Exposure to ISO 14971 risk management.
• Tools: Experience with eQMS/LMS or structured doc systems (e.g., SharePoint/Jira/Confluence) and calibration/supplier registers.

What you’ll love about working here

• Experience a Positive Work-Life Balance: We prioritize your well-being with hybrid and flexible working arrangements, making it easy to balance your personal and professional life.
• Own your Growth: Dive into endless learning opportunities with courses from Capgemini University and numerous external certifications. Benefit from digital learning platforms and specialized campuses in AI, Cloud, Data, and Sustainability. Propel your career with our award-winning Career Acceleration programs.
• Thrive in an Inclusive Environment: We don't just believe in inclusion; we live it. Bring your authentic self to work in a safe, flexible, and welcoming environment, supported by staff-led community groups and active allyship. We don't just believe in inclusion; we live it. Bring your authentic self to work in a safe, flexible, and welcoming environment, supported by staff-led community groups and active allyship. Don’t meet every single requirement for this role? Studies have shown women and people from diverse minority backgrounds are less likely to apply to jobs unless they meet every single requirement. At Capgemini, we are dedicated to building a diverse, inclusive, and authentic workplace, so if you’re excited about this role but your experience doesn’t align perfectly, we encourage you to apply and tell us what you can bring to the role.
• Work with Integrity: Join a company recognized by Ethisphere as one of the World’s most Ethical companies.
• Collaborate with Industry Leaders: Gain exposure to top global companies, including 145 of the Fortune 500, through your work with Capgemini.
• Showcase Your Skills: Participate in our internal annual global tech challenges and help address world issues.