
Senior Quality Engineer
2 weeks ago
Job Description:
This is an exciting opportunity to work as a Quality Assurance Specialist in the medical device sector. As a key member of our team, you will be responsible for ensuring product quality throughout the development phases.
Key Responsibilities:
- Ensure compliance with relevant policies and procedures
- Lead and support quality control activities including CAPA, audits, and supplier management
- Apply problem-solving methodologies to identify, prioritize, and resolve quality issues
- Plan, execute, report, and follow up on quality system audits
Requirements:
- Degree in quality engineering, life science or related field
- 3-5 years experience in a quality assurance role in the medical device sector
- Quality certification and lead auditor certification an advantage
- Knowledge of FDA's 21 CFR Part 820 and ISO 13485:2016
Skills and Qualifications:
- Experience in QA activities associated with design and development of medical devices
- Results-driven with ability to handle multiple tasks and operate in a fast-paced environment
- Excellent interpersonal skills and ability to work effectively as part of a team
- Excellent written and communication skills, fluency in English
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