Quality Engineer (Medical Devices)
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Job Location:
Monthly Salary:
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Key Requirements
- Solid experience in Medical Devices (DM) or Electromedical Products
- Strong knowledge of ISO 13485 and IEC 60601 standards
- Good understanding of Quality Management Systems (QMS)
- Experience in or exposure to Quality Audits (internal/external)
- Ability to review and validate technical documentation for compliance
- Experience collaborating with R&D teams on design and product quality
- Excellent English level (American company all documentation and meetings in English)
- Strong communication coaching and leadership skills
Responsibilities
- Review and validate all project/product documentation to ensure compliance with QMS and standards (ISO 13485 / IEC 60601)
- Support and coach project teams to meet quality and regulatory requirements
- Approve deliverables as QA representative
- Collaborate with cross-functional teams to resolve quality or regulatory issues
- Identify assess and manage risks related to safety quality and compliance
- Analyse non-conformities define and follow up CAPA actions
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
