Quality Engineer

At Medicareplus International, we pride ourselves on being 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. Join us in our commitment to excellence and become part of a culture that values collaboration and innovation.

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.

This is a full time office role at our head office in Alperton.

Responsibilities

• Provide day-to-day support and be responsible to maintain the effectiveness of the Quality Management System, including, but not limited to, Document Control, CAPA, Vigilance, Risk Management, Internal Audit, Post-Market Surveillance, Supplier Management.
• Monitoring and Assessment and Product Release activities
• Contribute to strategic improvement projects to improve business processes in line with the applicable regulatory requirements and Medicareplus Regulatory Strategy
• Prepare and present quality data to analyse quality trends and support investigations, remediation and improvement initiatives

Person Specification

• Strong Quality Management System knowledge – practical experience working within an ISO 13485 / medical device QMS, with an understanding of Document Control, CAPA, Change Control, Risk Management, Internal Audits and Product Release
• Medical device regulatory awareness – a good working knowledge of applicable medical device regulations, international standards and guidance, with the ability to keep up to date with emerging regulatory requirements
• Strong analytical and problem-solving skills – able to gather and interpret quality data from multiple sources, identify trends, support investigations and recommend practical, evidence-based improvements
• Supplier and subcontractor management experience – confident working with external manufacturers and suppliers, reviewing quality documentation such as batch records, CoAs/CoCs and sterilisation data, and addressing quality issues effectively
• Good communication and stakeholder-management skills – able to work effectively with suppliers, internal teams and auditors, present quality information clearly, and contribute constructively to audits, complaints, CAPAs and management review
• Organised, proactive and improvement-focused able to manage multiple priorities and tight deadlines, demonstrate initiative, identify opportunities to improve processes, and contribute to strategic quality and regulatory improvement projects

WHAT WE OFFER

• Salary £50,000-£55,000, plus bonus
• 25 days holiday + public/bank holiday
• Learning & Development - We encourage professional development and progression for all our team
• Lifestyle Benefits: Our Employee Assistance Programme offers a range of services including financial, wellbeing and counselling via Wisdom Wellbeing. A range of discounts are offered via Bright Exchange
• Online GP Services -Access to an online GP service via Livi
• Team building events