Software Design Assurance Engineer - (Remote)
About the Company
This organization employs a remarkable group of biologists, data scientists, engineers, investors, previous caregivers, and general compassionate individuals who have a vision for bringing extremely complex and critical diseases into clear and present focus. For this reason, they will never cease collaborating to improve the strength, speed, and ease of use of their technology, ensuring that every patient who seeks medical attention is promptly diagnosed with and treated for rapidly spreading diseases while there is still time to take action.
Responsibilities
- Serve as the principal quality reviewer for software verification and validation (V&V) documents, ensuring that they are accurate, clear, consistent, comprehensive, and compliant with all relevant industry standards and regulations.
- Protocols, reports (from unit tests to system validation), development specifications, requirement specifications, and so forth are examples of documents.
- Offer content and strategy recommendations for software verification and validation protocols and reports, including testing in accordance with specifications and the qualifications of tools, equipment, and other resources. assist with V&V activities by offering advice on methods, procedures for testing, etc.
- Finds and escalates opportunities to streamline current quality and test processes.
- Create and maintain SOPs and Work Instructions in accordance with other regulatory standards and Cytovale's QMS.
- Examine instances of non-conformance and carry out remedial and preventative measures in collaboration with pertinent cross-functional groups.
- Take the lead and engage in evaluations of product risk.
Qualifications
- A bachelor's degree in a suitable engineering or science field, such as bioinformatics
- Experience is a must for the ideal applicant with the creation of pharmaceuticals and/or medical devices
- Demonstrated proficiency with the five why, Ishikawa, and fishbone root cause analysis approaches
- Understanding of ISO 13485, ISO 14971, IEC 62304, GAMP 5, ANSI/CAN/UL, and 21 CFR 820.30
- The San Francisco Bay Area will serve as the position's basis.
- Ability to work in the US
- The role is to support software development and testing efforts two to three days a week on-site.
- 10% maximum for domestic travel
- Cytovale has a COVID-19 vaccination policy that is required. the capacity to operate on one's own
- Want to work for a fast-paced business where teamwork is highly valued
- Outstanding communicator, meticulous, and passionate GDP practitioner
- Able to sway without having direct authority Additional Responsibilities
- Leads and participates in product risk assessments
- Develops and updates SOPs and Work Instructions in accordance with Cytovale's QMS and other regulatory standards;
- Investigates non-conformities and coordinates corrective and preventive actions
- Collaborates with relevant cross-functional teams
- Finds and escalates opportunities for streamlining current test procedures and quality;
- Supports the transfer of product software and internal tools to manufacturing.
Benefits
- Fully remote work available
- The compensation plan includes a generous base salary, a yearly cash bonus based on performance
