Medical Device QA Engineer - ISO 13485 & QMS Expert

SRG (United Kingdom); Wembley; In loco; GBP 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

SRG - The Vertage Group is seeking a motivated Quality Engineer to maintain and improve our QMS for medical devices. The role emphasizes compliance with ISO 13485 and regulatory requirements, with collaboration across internal teams, suppliers, and external stakeholders to drive quality improvements.

The ideal candidate will oversee document control, CAPA, change control, internal audits, PMS, and product release processes, while reviewing quality data to identify trends and support

Competenze

• Experience with ISO 13485 quality management systems in medical devices.
• Strong analytical skills to interpret quality data and identify trends.
• Proven ability to investigate issues and implement corrective actions.

Mansioni

• Maintain and support the QMS, including document control, CAPA, change control, internal audits, and PMS.
• Support product monitoring, assessment, and release activities.
• Review quality records and documentation for regulatory compliance.
• Prepare and present quality data to support investigations and improvements.
• Lead root cause investigations and CAPA activities; implement corrective actions.
• Collaborate with suppliers to ensure quality requirements are met.
• Support supplier quality documentation reviews (CoAs, CoCs) and sterilisation docs.
• Participate in internal, supplier, customer, and regulatory audits.

Conoscenze

ISO 13485

Quality data analysis

Root cause analysis

Auditing

Regulatory knowledge

Stakeholder management

Descrizione del lavoro

SRG - The Vertage Group is seeking a motivated Quality Engineer to maintain and improve our QMS for medical devices. The role emphasizes compliance with ISO 13485 and regulatory requirements, with collaboration across internal teams, suppliers, and external stakeholders to drive quality improvements.

The ideal candidate will oversee document control, CAPA, change control, internal audits, PMS, and product release processes, while reviewing quality data to identify trends and support