Key Resposibilities
- Maintain and support the ISO 9001 and ISO 13485 Quality Management Systems.
- Manage and coordinate Non-Conformance Reports (NCRs), investigations, corrective actions and follow-up activities.
- Administer and coordinate Change Control activities from initiation through implementation and closure.
- Support CAPA management and effectiveness reviews.
- Control and maintain quality documentation, SOPs, records and quality databases.
- Support supplier qualification, monitoring and performance evaluation activities.
- Assist with customer complaints, investigations and trend analysis.
- Support internal, supplier, customer and certification body audits.
- Participate in continuous improvement projects and quality system enhancements.
- Prepare quality metrics, reports and Management Review inputs.
- Provide quality support to operational departments and business improvement initiatives.
- Support regulatory and compliance activities associated with the company's medical device operations.
Candidate Requirements
Essential
- Minimum 5 years' experience working within a Quality Management System in a regulated industry.
- Experience working within ISO 9001 and/or ISO 13485 environments.
- Demonstrable experience managing NCRs, investigations and Change Control processes.
- Strong document control and quality systems administration experience.
- Excellent organisational and communication skills.
- Ability to work independently whilst contributing effectively as part of a team.
Proficient in Microsoft Office applications.
Desirable
- Internal Auditor qualification or practical auditing experience.
- Experience participating in customer, supplier and certification body audits.
- Experience within medical device, pharmaceutical, healthcare or regulated distribution industries.
- Experience with CAPA management and root cause investigations.
- Knowledge of supplier quality management processes.
Location: Haywards Heath, West Sussex (On-site)
Reporting to: Head of Quality
We recognise that candidates may not meet every requirement listed in this role profile. If you are excited about the opportunity and believe you can make a meaningful contribution to our business, we encourage you to apply.