Medical Device QA Specialist — ISO 13485 & MDR Expert

Bioceramed; Guimarães; Hybrid; EUR 35,000 - 52,000; Full time

Job summary

Bioceramed in Portugal is seeking a Quality Assurance Specialist to support the maintenance and continuous improvement of the Quality Management System for medical devices. The role covers documentation control, monitoring quality indicators, investigations and CAPA, audits, supplier evaluations, and design/change control participation, with strong cross‑functional collaboration.

The ideal candidate has a degree in a relevant field and at least four years of QA experience, and is proficient in

Qualifications

• Degree in Biomedical Engineering, Bioengineering, Biotechnology, Pharmacy, Quality Management, Industrial Technology, or related field.
• Minimum of 4 years of QA 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

QMS knowledge

Analytical skills

Organisational skills

Attention to detail

Independent worker

Cross-functional coordination

Communication

Education

Biomedical Engineering degree

Quality Management training

Tools

QMS software

Job description

Bioceramed in Portugal is seeking a Quality Assurance Specialist to support the maintenance and continuous improvement of the Quality Management System for medical devices. The role covers documentation control, monitoring quality indicators, investigations and CAPA, audits, supplier evaluations, and design/change control participation, with strong cross‑functional collaboration.

The ideal candidate has a degree in a relevant field and at least four years of QA experience, and is proficient in