Quality Assurance Professional
3 weeks ago
Arevna is seeking a Quality Assurance Professional to join our team in ensuring compliance with medical device regulations and quality standards. The ideal candidate will have at least 3 years of experience in quality assurance or quality control within a medical device environment.
The estimated salary for this position is around $85,000 per year, depending on the location and experience.
Key Responsibilities:
- Implement and maintain a Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations.
- Conduct inspections, testing, and release activities for components and finished medical device products.
- Support internal and external audits, including preparation, participation, and follow-up on corrective actions.
- Collaborate with cross-functional teams to address non-conformities, deviations, CAPAs, and complaints to drive resolution and compliance.
Required Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- Minimum of 3 years of experience in quality assurance or quality control within a medical device environment.
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and MDR requirements.
- Experience with CAPA, non-conformance investigations, and root cause analysis.
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