Software Quality Assurance Engineer.
Reports To: Senior Director, Regulatory Affairs and Quality Assurance
Location: San Jose, CA.
Job Type: Full Time - onsite
5+ years in the Medical Device Industry.
- In-depth knowledge and experience in Quality Assurance, Operations, and Manufacturing and strong background in 21 CFR Part 820, 21 CFR Part 11, and ISO 13485:2016.
- Ability of leading customer complaint activities, including root cause investigations and complaints closure.
- Experience of participating and representing QA in external audits by the Notified Body and FDA.
- Ability to represent QA in risk management, new product development, and design changes. Knowledge of BS EN ISO 14971:2019 and IEC 60601-1.
- An expert in IEC 62304 (Software Development Life Cycle), design control, design verification and software defects reporting and management, risk analysis, computer system validation, software validation process per 21 CFR 820.3(z) and (aa) and 820.30(f) and (g), Quality system regulations, and audits.
- Experience in writing, reviewing, and approving medical device software deliverables. System requirements, sub-system requirements specification, software architecture document, software description document, software requirements specification, software test plan, unit testing, integration testing, and risk analysis.
- Working knowledge of Collateral Standards such as: IEC 60601-1; IEC 60601-1-2; IEC 62366, IEC 62304.
- Strong Project Management skills in leading cross-functional teams, including engineers. Project execution with multiple phases - Deliverables from inception to production. Developing and defining project scope, tasks, deliverables, and resource requirements.
- Experience in successfully driving multiple programs and projects level products from conception to implementation. Risk management identification and mitigation.
- Participate and provide quality assurance oversight and support throughout the development of a product.
- Represent QA in new product development project teams to ensure all regulatory requirements are met through the development process and defining the requirements.
- Support post market activities. Assess impact of post-market changes on product, system & software design.
- Support manufacturing and equipment qualification, process control, and training programs.
- Prepare/review/approve Quality related and design documents (SOPs, qualification protocols/reports)
- Lead multi-functional discussions during significant investigations and root cause Investigations for potential product quality impact to ensure safety and quality of Software products.
- Support and help organization in maintaining product and quality system compliance.
- Participate and represent QA during FDA and NB site audits.