QMS Engineer – Medical Device Manufacturer
Location: Oxford – Hybrid Role
Role Summary:
GxPeople Global is partnering with a well-established Medical Device Manufacturer to find their next team member—a QMS Engineer who will play a key role in maintaining and improving the Quality Management System (QMS). This role offers a fantastic opportunity for an experienced quality professional to contribute to the company’s compliance with ISO 13485, FDA, and global regulatory standards, while also supporting process improvements and technical projects.
As part of the Quality team, this role provides a secure, full-time position with hybrid working (3 days in-office, 2 from home). You will collaborate closely with internal teams, suppliers, and regulatory bodies, ensuring compliance, efficiency, and continuous improvement within the QMS framework.
Key Responsibilities:
QMS Ownership & Compliance
Maintain and develop Quality Management System (QMS) procedures and documentation.
Ensure compliance with ISO 13485:2016, MDSAP, FDA, and other global regulations.
Conduct gap analyses to assess compliance with evolving standards and regulatory requirements.
Process Improvement & CAPA Management:
Utilize quality investigative tools (Ishikawa, FMEA, Five Whys, Is/Is Not Analysis) to determine root causes of quality issues.
Manage, implement, and maintain Corrective and Preventive Actions (CAPAs) to enhance quality and compliance.
Develop flowcharts and process documentation to improve QMS understanding and streamline workflows.
Drive continuous improvement initiatives to create more efficient, agile quality processes.
Auditing & Regulatory Support:
Plan and conduct internal and supplier audits, ideally as an ISO 13485:2016 Internal Auditor.
Support and co-host Notified Body, regulatory authority, and customer audits alongside senior quality leadership.
Conduct audits of Design History Files (DHF) and Device Master Records (DMR).
Training & Cross-Functional Collaboration:
Provide QMS induction training and ongoing training for teams.
Train cross-functional teams in advanced quality planning tools (DFMEA, PFMEA, PPAP).
Support New Product Development (NPD) processes, ensuring quality and compliance at every stage.
Technical & Risk Management Support:
Contribute to product risk assessments and risk management activities in line with ISO 14971.
Assist with device testing activities, including IEC 60601-1 and IEC 60601-1-2.
Support in the preparation of Technical Files for regulatory submissions.
Qualifications & Experience:
5+ years of experience in Quality Assurance within the Medical Device industry.
Strong working knowledge of ISO 13485:2016, MDSAP, EU MDR (2017/745), and FDA requirements.
Lead Auditor training and certification is highly desirable.
Experience in investigational quality tools (e.g., Fishbone Analysis, Pareto, FMEA).
Familiarity with IEC 60601 standards (60601-1 Electrical Safety, 60601-1-2 EMC, 60601-1-6 Usability).
Risk Management experience in accordance with ISO 14971.
Strong communication and collaboration skills to work effectively with cross-functional teams.
What’s in It for You?
Competitive salary with a secure, full-time hybrid role.
Opportunity to work with a leading Medical Device Manufacturer in a growing industry.
Exposure to cutting-edge technology and regulatory frameworks.
Work alongside highly experienced professionals, enhancing your skills and career development.
Ongoing training and development opportunities.
Flexible working arrangements (3 days in-office, 2 from home).
If you are an experienced QMS Engineer looking for an exciting new opportunity with a reputable Medical Device Manufacturer, please apply to this advert or get in touch for more details.