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About the Role
We are seeking a Quality Engineer to ensure our Quality Management System remains fully compliant with relevant Medical Device Directives, Regulations, International Standards, and customer specifications.
Responsibilities
- Provide day-to-day support and maintain the effectiveness of the Quality Management System, including Document Control, CAPA, Vigilance, Risk Management, Internal Audit, Post-Market Surveillance, and Supplier Management.
- Perform Monitoring and Assessment and Product Release activities.
- Contribute to strategic improvement projects to enhance business processes in line with regulatory requirements and Medicareplus Regulatory Strategy.
- Prepare and present quality data to analyze trends, support investigations, remediation, and improvement initiatives.
Requirements
- Strong Quality Management System knowledge with practical experience in an ISO 13485 / medical device QMS.
- Understanding of Document Control, CAPA, Change Control, Risk Management, Internal Audits, and Product Release.
- Medical device regulatory awareness with a good working knowledge of applicable regulations, international standards, and guidance.
- Ability to stay updated with emerging regulatory requirements.
- Strong analytical and problem-solving skills to gather and interpret quality data, identify trends, support investigations, and recommend improvements.
- Supplier and subcontractor management experience, including reviewing quality documentation and addressing quality issues.
- Good communication and stakeholder-management skills to work effectively with suppliers, internal teams, and auditors.
- Ability to present quality information clearly and contribute constructively to audits, complaints, CAPAs, and management review.
- Organized, proactive, and improvement-focused with the ability to manage multiple priorities and deadlines.
- Demonstrate initiative and identify opportunities to improve processes.
Skills
- Quality Management System
- ISO 13485
- Document Control
- CAPA
- Change Control
- Risk Management
- Internal Audits
- Product Release
- Medical Device Regulations
- Analytical Skills
- Problem-Solving Skills
- Supplier Management
- Subcontractor Management
- Communication Skills
- Stakeholder Management
Location
- Alperton
Work Type
- Full-time
- Office-based
Salary/Compensations
- £50,000-£55,000
Benefits
- Bonus
- 25 days holiday + public/bank holiday
- Learning & Development opportunities
- Employee Assistance Programme (Wisdom Wellbeing)
- Discounts via Bright Exchange
- Online GP Services (Livi)
- Team building events
About the Company
- Medicareplus International is a leading force in advanced wound care and infection prevention.
- Our mission focuses on creating innovative products that enhance patient care and support healthcare professionals.
- We foster a culture that values collaboration and innovation.