Quality Engineer
Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Our client is seeking a Quality Engineer with experience in the medical device industry to support quality assurance and regulatory compliance efforts across product development and manufacturing. The ideal candidate will have a strong understanding of ISO 13485 FDA 21 CFR Part 820 risk management (ISO 14971) and other applicable quality standards and regulations.
Roles & Responsibilities:
- Support the development implementation and maintenance of quality systems in compliance with regulatory requirements.
- Strong experience and understanding of supplier controls.
- Conduct root cause analysis and implement corrective and preventive actions (CAPAs).
- Collaborate with cross-functional teams to ensure quality is built into product design and processes.
- Assist in the creation and review of quality documentation including SOPs protocols and reports.
- Bachelors degree in engineering life sciences or a related field.
Employment Type
Full Time
