Senior Compliance Officer
1 week ago
Arevna is hiring a Quality Assurance Specialist to lead our quality management system efforts. The ideal candidate will have a strong background in medical device quality and regulatory affairs.
**Key Responsibilities:**
- Developing and implementing QMS policies, procedures, and processes.
- Conducting regular audits and assessments to ensure compliance with ISO 13485 and FDA 21 CFR Part 820.
- Investigating and resolving non-conformities, deviations, and CAPAs.
- Collaborating with cross-functional teams to drive resolution and compliance.
**Requirements:**
- 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.
- Excellent analytical, problem-solving, and communication skills.
We offer a salary range of $70,000 - $100,000 per year, based on experience.
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