Medical Device Quality Expert
5 days ago
Arevna is seeking a highly skilled Medical Device Quality Expert to join our team. This role involves ensuring compliance with medical device regulations and quality standards.
**Key Responsibilities:**
- Implement and maintain 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.
- Assist in the validation of manufacturing processes, equipment, and software (IQ/OQ/PQ).
- Review and approve batch records, change control documents, and quality-related documentation.
- Maintain and update quality records, including product inspection reports, NCR logs, and calibration schedules.
- Support risk management processes (ISO 14971) and ensure adherence to design control requirements.
- Train staff on quality standards, procedures, and best practices.
- Monitor trends, metrics, and KPIs to identify and implement continuous improvement opportunities.
**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 (CMO experience preferred).
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and MDR requirements.
- Experience with CAPA, non-conformance investigations, and root cause analysis.
- Familiarity with validation protocols (IQ/OQ/PQ) and risk management principles (ISO 14971).
- Proficiency in MS Office Suite; experience with QMS software is a plus.
- Strong analytical, problem-solving, and communication skills.
We offer an estimated salary range of $80,000 - $110,000 per year, depending on experience.
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