Medical Device QA Specialist | ISO 13485, MDR & CAPA

Hydrumedical SA; Guimarães; On-site; EUR 42,000 - 54,000; Full time

Job summary

Hydrumedical SA is seeking a Quality Assurance Specialist to support the Quality Management System, review documentation, monitor quality indicators, and drive CAPA activities. The role requires a degree in a relevant field and at least 4 years of QA experience in medical devices.

The successful candidate will participate in audits, supplier evaluations, and change control meetings, contributing to risk assessments and continuous quality improvement across the organisation.

Qualifications

• Minimum of 4 years of Quality Assurance experience in the medical device industry.
• Experience with ISO 13485 and MDR is mandatory.
• Experience with MDSAP and risk management is preferred.

Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System.
• Review and control quality documentation.
• Monitor quality indicators and prepare reports.
• Manage nonconformities, investigations, and CAPA activities.
• Participate in internal and external audits.
• Support supplier evaluations and customer complaint handling.
• Promote quality awareness across the organisation.
• Participate in design and change control meetings.
• Perform process risk assessments.
• Report quality status, risks, and improvement opportunities to the Quality Manager.

Skills

Quality Management Systems

Analytical skills

Organisational skills

Attention to detail

Communication

Education

Biomedical Engineering, Bioengineering, Biotechnology, Pharmacy, Quality Management, Industrial Technology or related field

Job description

Hydrumedical SA is seeking a Quality Assurance Specialist to support the Quality Management System, review documentation, monitor quality indicators, and drive CAPA activities. The role requires a degree in a relevant field and at least 4 years of QA experience in medical devices.

The successful candidate will participate in audits, supplier evaluations, and change control meetings, contributing to risk assessments and continuous quality improvement across the organisation.