Quality Assurance Specialist
Há 17 horas
guimarães, braga, Portugal
Hydrumedical SA
Tempo integral
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Oct, 21 - 2026 1 min. read
Position
Quality Assurance Specialist
Schedule
1.0 FTE
Type of Offer
Full-time
Education and Experience
- Degree in Biomedical Engineering, Bioengineering, Biotechnology, Pharmacy, Quality Management, Industrial Technology, or a related field;
- 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.
Certifications
- ISO 13485 Quality Auditor certification is preferred;
- Training in risk management according to ISO 14971 is preferred.
Skills
- Knowledge of Quality Management Systems and continuous improvement methodologies;
- Strong analytical, organisational, and attention-to-detail skills;
- Ability to work independently, proactively, and with a results-oriented approach;
- Good communication and cross-functional coordination skills.
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.