Quality Assurance Specialist

Há 17 horas

guimarães, braga, Portugal Hydrumedical SA Tempo integral

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.