Job Responsibilities and Description
- Develop, implement, and maintain efficient, scalable quality system and design control process compliant with ISO 13485, FDA 21 CFR 820.30, ISO 14971, IEC 62304 and other relevant regulations.
- Ensure that compliance with customer requirements, risk management, quality, and design control standards is demonstrated throughout design and development, with a particular emphasis on Hardware and Software in a Medica Device (SaMD), Cybersecurity, AI/ML and consumables.
- Operationalize and maintain quality tools such as Quality System Software Green Light Guru (GLG) and PDM software.
- Champion the design control process and help in developing design control documentation.
- In collaboration with regulatory advisors, contribute to regulatory strategy, plan, and requirements for FDA Q-subs, IDE, Clinical Studies, and Product Approval submissions.
- Lead the creation of technical, quality, and clinical documentation for clinical trial submissions and regulatory approvals (FDA, CE, etc.).
- Generate and maintain risk management files supporting product development, including Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related field
- 6+ years experience in quality and regulatory affairs with rigorous design control processes for medical devices with consumables, hardware, and software.
- Experience in implementing and managing QMS and Design Controls in start-up environment.
- Proven experience working across all stages of medical device development, from concept through design transfer to manufacturing.
If you have interest in this role then be sure you are willing and able to work or relocate to Southern California!
