We are a fast-moving, innovative medical company that manufactures and distributes medical devices. These devices are distributed worldwide. We are looking for a dynamic and driven personality to work as a team in our fast-growing company.
We are seeking a Part-Time Quality Manager – Medical Devices (1 Day per Week)
About the Role
We are seeking an experienced Part-Time Quality Manager to oversee and maintain our Medical Device Quality Management System (QMS). This role is ideal for an independent quality professional who can provide expert guidance on a flexible basis, ensuring our quality systems remain compliant with UK, EU, and international regulatory requirements.
Working approximately one day per week, you will be responsible for maintaining compliance, supporting audits, managing quality processes, and driving continuous improvement across our medical device operations.
Key Responsibilities
Quality Management System (QMS)
- Maintain and continuously improve the company's Quality Management System (QMS).
- Develop, review and update Standard Operating Procedures (SOPs), policies and quality documentation.
- Ensure ongoing compliance with ISO 13485, UK MDR, EU MDR and FDA 21 CFR requirements, where applicable.
- Maintain Device Master Records (DMRs), Technical Documentation and quality records.
Audits and Regulatory Compliance
- Plan, conduct and report on internal quality audits.
- Prepare the business for external audits and inspections by Notified Bodies and regulatory authorities.
- Monitor supplier quality performance and maintain supplier approval processes.
- Support regulatory compliance activities and quality reporting.
Quality Assurance and Risk Management
- Lead investigations into non-conformances and implement Corrective and Preventive Actions (CAPAs).
- Facilitate risk management activities in accordance with ISO 14971.
- Manage product safety issues, customer complaints and adverse event reporting where required.
- Monitor quality metrics and recommend improvements to strengthen compliance and operational performance.
Person Specification
Essential Qualifications
- Bachelor's degree in Science, Engineering, Life Sciences or a related discipline.
- Minimum 3–5 years' experience in Quality Assurance or Regulatory Affairs within the medical device industry.
- Demonstrable experience establishing, maintaining or improving a Medical Device Quality Management System.
Essential Knowledge & Experience
- Expert knowledge of ISO 13485.
- Strong understanding of UK MDR, EU MDR and/or FDA 21 CFR Part 820.
- Experience managing CAPAs, non-conformances, deviations and root cause investigations.
- Practical knowledge of ISO 14971 risk management.
- Experience planning and leading internal audits and supporting external regulatory inspections.
- Experience managing supplier quality and technical documentation.
Skills
- Excellent organisational and documentation skills.
- Strong analytical and problem-solving abilities.
- Ability to work independently with minimal supervision.
- Excellent communication and stakeholder management skills.
- High attention to detail and commitment to quality and compliance.
- Effective time management with the ability to prioritise activities within limited weekly hours.
Working Pattern
- Part-time
- Approximately 1 day per week (flexible by agreement)
- Hybrid or remote working may be considered, with occasional onsite attendance if required.
Salary
£50,000–£70,000 per annum (pro rata), depending on qualifications and experience.
What We Offer
- Flexible working arrangements.
- Opportunity to make a significant impact within a growing medical device business.
- Collaborative and professional working environment.
- Competitive day rate or salary, depending on experience.
If you are an experienced medical device quality professional looking for a flexible role where you can apply your expertise to maintain and improve a compliant Quality Management System, we would welcome your application.
Start date: Immediate
Job Type: Part-time
Pay: £50,000.00-£70,000.00 per year
Experience:
- Quality assurance: 1 year (preferred)
Work Location: Hybrid remote in Basildon SS14 3AX
