Quality Systems Specialist

2 days ago


Glebe, Australia Capgemini Engineering Full time

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

**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.
- **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.

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design



  • Glebe NSW, Australia Capgemini Engineering Full time $90,000 - $120,000 per year

    At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world's most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and...

  • Data Specialist

    7 hours ago


    Glebe, Australia The Benevolent Society Full time

    **Full-time position based at our National Office in Glebe**: - **Flexible Friendly organisation, WFH & part time options available**: - **Competitive remuneration + Salary Packaging** The Benevolent Society supports Australians by offering integrated support services for children, young people, families, people with disability, older Australians and...


  • Glebe, Australia The Benevolent Society Full time

    **3 month contract position based in Sydney or Brisbane**: - **Flexible Friendly organisation**: - ** $35.97 per hour plus superannuation** We are Australia’s first charity, providing a range of services across New South Wales, Queensland and South Australia. We are a not-for-profit and non-religious organisation that has assisted people, families and...


  • Glebe, Australia Exquisite Brows and Spa Full time

    The applicant must be expert in eyebrow shaping with thread. Other services are a plus which includes Eyelash Extensions, Lash Lift, Tinting, Facial and Waxing. You need to open the store on time and clock in to the system, than do the dusting of the shop front and wipe the chairs and mirrors with glass cleaner and sweap the floor at the day end sweep and...

  • Payroll Specialist

    1 week ago


    Glebe, Australia Médecins Sans Frontières Australia Full time

    Reporting to the Senior Business Partnering Manager this parental leave 4 month contract role (starting in Aug) will manage all aspects payroll for 140 domestic office staff, and 100 international field based staff for MSF Australia and MSF New Zealand. With a focus on end to end payroll this collaborative role will ensure compliance across financial...


  • Glebe, Australia The Benevolent Society Full time

    **10 month full time** position based at our **National Office in Glebe**: - $73k - $78k + Salary Packaging - Flexible Friendly organisation, WFH & part time options available **About the role** As our Community Services Consultant, you will be the first point of contact for all current and potential clients of The Benevolent Society including our older...


  • Glebe, Australia Médecins Sans Frontières Australia Full time

    Reporting to the Senior Fundraising Manager - Philanthropy this accountable role will drive revenue through building and maintaining strong relationship with high-net-worth donors and prospects. You will be accountable for the solicitation of gifts, the cultivation and stewardship of a portfolio of individual donors giving at a high value, and for managing...


  • Glebe, Australia The Benevolent Society Full time

    **Full time position based at our National Office in Glebe**: - **$74k - $79k inclusive of Super + Salary Packaging**: - **Flexible Friendly organisation, WFH & part time options available** **About the role** As our Community Services Consultant, you will be the first point of contact for all current and potential clients of The Benevolent Society...


  • Glebe, Australia The Benevolent Society Full time

    **Full time position based at our National Office in Glebe**: - ** $74k - $79k inclusive of Super + Salary Packaging**: - ** Flexible Friendly organisation, Hybrid work options available** **About the role** As our Community Services Consultant, you will be the **first point of contact** for all current and potential clients of The Benevolent Society...


  • Glebe, Australia The Benevolent Society Full time

    **Part-time position based at our National Office in Glebe**: - ** $79k - $84k Pro-Rata Inclusive of Super + Salary Packaging**: - **Flexible Friendly organisation, Hybrid work options available** **About the role** As our Community Services Consultant, you will be the **first point of contact** for all current and potential clients of The Benevolent...