Full‑time | ISO 13485 Medical Device Environment
Orthoplastics, part of the Viant Group—a global medical manufacturing organisation with 25+ sites worldwide—produces specialist materials and components that help millions of patients every year. We’re expanding our Quality team at our Orthoplastics site and are seeking an experienced Quality Assurance Specialist with strong ISO 13485 experience, ideally within medical devices or supplying into the sector.
The Role
- Maintain and improve the ISO 13485 Quality Management System.
- Manage our eQMS system (documents, CAPA, NCRs, audits, change control).
- Lead supplier quality qualification activities including audits, SCARs, investigations, and performance reviews.
- Support manufacturing teams to resolve issues and drive improvements.
- Own and lead non-conformances as required, conducting effective root cause analysis and implementing effective corrective and preventive actions.
- Prepare for and host customer and external audits.
- Produce clear quality metrics and trend analysis.
- Ensure compliance with ISO 14971 Risk Management within the QMS.
- Support the implementation of regulatory changes to the QMS.
- Respond to and support Customer queries and requests.
What You’ll Bring
- Experience in medical devices or regulated medical supply chain.
- Strong knowledge of CAPA, NCRs, audits, and QMS compliance.
- Hands‑on experience with Q‑Pulse or similar eQMS.
- Confident working with suppliers and cross‑functional manufacturing teams.
- A proactive, improvement‑driven mindset.
- Thorough and organised approach in a fast paced setting.
Our Values
We’re looking for someone who demonstrates:
- Customer Orientated – quality decisions that protect patients and customers.
- Teamwork – collaborative and supportive.
- Agility – adaptable in a fast‑moving environment.
- Owning It – takes responsibility and delivers.
- Accountable – ensures compliance and high standards.
Why Orthoplastics
Join a growing, values‑driven medical manufacturer within the Viant Group, where your work directly improves patient outcomes worldwide.
Working Hours
· Monday to Thursday 08.30 – 17.00, Friday 08.30-13.30 (35 hour working week), which includes breaks.
· Duties and hours may vary dependent upon workload
Apply now on Indeed and help us deliver quality that matters.
Pay: £39,000.00-£42,000.00 per year
Benefits:
- Bereavement leave
- Canteen
- Company events
- Company pension
- Cycle to work scheme
- Employee discount
- Financial planning services
- Free parking
- Health & wellbeing programme
- Life insurance
- On-site parking
- Sick pay
Application question(s):
- What Quality Management Standards have you previously worked with?
- What involvement have you previously had in regulatory/certification audits (e.g. ISO 13485 certification audit)?
- What are your salary expectations?
- What is your notice period?
Work Location: In person
