Quality Engineer

Medicareplus International; Greater London; On-site; GBP 50,000 - 55,000; Full time

Benefits offered by this job

25 days holiday

Learning & Development

Employee Assistance Programme

Online GP Services

Team building events

Wisdom Wellbeing discounts

Bright Exchange discounts

Job summary

Medicareplus International is seeking a Quality Engineer to ensure our Quality Management System complies with Medical Device Directives, Regulations, International Standards, and customer specs. This full-time office role is based at our head office in Alperton, London.

You will maintain QMS effectiveness, support CAPA and risk management, oversee product release, audits and supplier management, and contribute to regulatory strategy with analytical quality data.

Qualifications

• Strong Quality Management System knowledge – ISO 13485 / medical device QMS, with document control, CAPA, Change Control, Risk Management, Internal Audits and Product Release.

Responsibilities

• Maintain effectiveness of the Quality Management System including Document Control, CAPA, Vigilance, Risk Management, Internal Audit, Post-Market Surveillance and Supplier Management.
• Monitor and assess product release activities.
• Contribute to strategic quality and regulatory improvement projects.
• Prepare and present quality data to analyse trends and support investigations.

Skills

Quality Management System

Regulatory awareness

Analytical & problem-solving

Supplier management

Communication & stakeholder management

Organised & proactive

Job description

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