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Director of Quality Assurance and Regulatory Affairs
2 months ago
**About Melio Life Science**
We are a leading medical device organization dedicated to delivering innovative solutions that improve patient outcomes. Our commitment to quality and regulatory excellence is unwavering, and we are seeking a seasoned professional to lead our Quality Assurance and Regulatory Affairs team.
**Job Summary**
We are seeking a highly experienced Director of Quality Assurance and Regulatory Affairs to oversee our product design, performance, and processes to meet company quality standards. The successful candidate will work closely with our manufacturing, engineering, and support teams to achieve quality objectives, ensuring compliance with regulatory standards and readiness for inspections.
**Key Responsibilities:**
- **Regulatory Compliance**: Act as the main contact for ISO standards, overseeing audits and implementing necessary systems to ensure compliance with internal, customer, ISO, and FDA requirements.
- **Quality Management System**: Maintain and enhance the Quality Management System to align with internal, customer, ISO, and FDA requirements, ensuring seamless integration with our business operations.
- **Audit and Inspection Management**: Plan, conduct, and supervise internal audits to ensure compliance with quality standards, and manage the inspection processes for incoming, in-process, and final products to meet quality requirements.
- **Training and Development**: Train and support staff in achieving quality objectives and maintaining standards, ensuring a culture of quality excellence throughout the organization.
- **Supplier Management**: Liaise with suppliers, OEMs, and the parent company regarding certifications, product performance, and quality issues, ensuring a robust and reliable supply chain.
- **CAPA and Document Control**: Oversee CAPA, validation, technical files, and complaint management to address quality issues, and ensure compliance with regulatory standards.
- **Risk Management**: Independently review risk management studies, manage document control, and ensure compliance with regulatory standards, identifying and mitigating potential risks to our products and operations.
**Requirements:**
- **Regulatory Expertise**: In-depth understanding of regulatory and quality practices across the product lifecycle, with a strong knowledge of ISO 13485 and experience working with regulatory bodies like UL, ISO, and FDA.
- **Leadership Experience**: Over 8 years of experience in quality assurance and regulatory roles, with a proven track record of leading high-performing teams and driving quality excellence.
- **Analytical Skills**: Ability to interpret engineering drawings and documentation, with proficiency in algebra, statistics, and probability for data analysis.
- **Certifications**: ASQ certification is preferred, but not required.
