Quality Engineer - Medical Devices & QMS Compliance

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

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.