- Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation.
- Understand clinical applications, workflow and user needs
- Develop software-related verification and validation strategies for the R&D organization and ensure the execution of the strategies.
- Serves as a technical resource for risk management activities for software in compliance with ISO 14971 and IEC 62304.
- Develop test plans, and test cases based upon the product and component level requirements.
- Partner with Human Factors SMEs and R&D to assess the usability of the software throughout design and development
- Review and approve V&V system maintenance such as reworks and modification and tracking related to software upgrades.
- Perform root cause analysis of identified design issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.
- Perform audits of Design History Files and support both internal and external audits.
- Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
- Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule.
- Work collaboratively and efficiently in a fast-paced environment with minimal supervision and guidance.
- Maintain trained status for, and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory compliance.
- As the voice of quality, this role will apply and promote best-practice use of statistical tools and techniques throughout the organization.
- Other QMS activities not specified here and as assigned.
- BS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or other related programs.
- Minimum of 8 years of Quality Engineering work experience in the medical device field with complex medical devices, i.e. devices that include capital hardware, disposable hardware, and software.
- and a minimum of 3 years' experience in a development QE function.
- Experience in meeting Design Control and DHF requirements with NPD teams.
- Well versed in the complete Quality Management System to meet US FDA and ISO/MDR requirements with an emphasis on IEC 62304.
- Experience with Risk Management, FMEA, Hazard Analysis.
- Experienced with statistical skills to define/train on test sample size and data analysis techniques.
- Experienced in Microsoft Office, Google Suite, JIRA, Jama, and ePLM/eQMS systems.
- Must be a self-starter, team builder, and excellent in verbal and written communication.
- Preferred: Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc.
- Passionate about SW and technologies for healthcare
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Staff Quality Engineer - San Carlos, United States - HealthCare Recruiters International
Description
Client:
Our client is a well-funded start-up company that is building the future of medical robotics. Their next-generation robotic platform targets early diagnosis and treatment of patients across multiple disease states.
Job Location: (Hybrid) Open to San Jose or San Carlos locations
A Day In The Life Of Our Staff DQA Software Engineer:
About You:
Workplace Type: Hybrid
