Job Description: Director of Quality Assurance - Medical Device Company
Location: Bay Area
Position Overview: We are seeking an experienced and highly motivated Director of Quality Assurance to lead and manage our quality systems in a dynamic, venture capital-backed medical device environment. The ideal candidate will have a strong background in hosting FDA audits, obtaining ISO 13485 certification, and managing comprehensive quality systems across all phases of product development and manufacturing. This role is pivotal in ensuring compliance with regulatory requirements and maintaining the highest standards of product quality and safety.
Key Responsibilities:
- FDA Compliance & Audits: Lead and host FDA audits, ensuring the company meets all regulatory requirements. Maintain and improve our quality management system to support FDA compliance.
- ISO 13485 Certification: Successfully obtained and maintained ISO 13485 certification. Continuously monitor and update processes to adhere to the latest standards.
- Quality Systems Management: Oversee the entire quality management system, including incoming quality control, in-process quality control, and design control. Ensure that all processes meet internal and regulatory standards.
- Design Control: Manage and maintain design control processes, ensuring that product design and development adhere to regulatory requirements and quality standards.
- Sterilization & Clean Room Management: Ensure that sterilization processes are validated and verified according to industry standards. Manage clean room operations, ensuring compliance with regulatory and quality standards.
- Validation & Verification: Lead validation and verification activities across the company’s processes and products, ensuring all systems and products meet quality and regulatory standards.
- Complaint Handling & Regulatory Registration: Oversee the complaint handling system, ensuring that it is registered with the FDA and compliant with all relevant regulations. Ensure that the company’s facilities and processes are properly registered with the FDA.
- Class II Medical Device Expertise: Leverage extensive experience in managing quality systems for Class II medical devices, ensuring that all products meet regulatory requirements.
- Small Team Leadership: Lead a small, highly skilled team within a collaborative environment. Provide mentorship and guidance to team members, fostering a culture of continuous improvement and excellence.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
- Minimum of 10 years of experience in quality assurance within the medical device industry, with at least 5 years in a leadership role.
- Proven experience hosting FDA audits and obtaining ISO 13485 certification.
- Strong knowledge of regulatory requirements for Class II medical devices, including experience with disposables, sterilization, and clean room management.
- Experience in a venture capital-backed environment is highly desirable.
- Demonstrated ability to manage validation and verification processes.
- Excellent communication and leadership skills, with the ability to work effectively in a small team environment.
