Vacancy expired!
The recruitment team at Myticas Consulting is looking for an experienced Software QA Engineer who would be interested in a remote contract opportunity headquartered within the Lake County, IL region.
Top 3-5 Requirements:- 5+ years of industry experience in Quality Assurance, Development or healthcare related field.
- Bachelor's degree or equivalent is required; preferably in sciences, engineering or other technical/scientific area.
- Software medical device experience
- Medical device regulation IEC 62304, 21 CFR 820.30 and EU MDR
- Experience creating and maintaining qms (quality mgmt. system) documents
- Experience in software quality assurance in regulated space
- Experience in Medical devices, specifically development of Software Medical Devices is desired.
- Perform QA activities related to Software as a Medical Device (SaMD) and Digital Health Software Product Development
- Ensure compliance with client's software lifecycle policies and procedures.
- Perform design control and risk management activities according to client's Quality System
- Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met.
- Support the creation of regulatory submission documentation.
- Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
- Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
- Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements.
- Write/review policies/processes/procedures and related documents for the development of SaMD's and Digital Health products in compliance with global regulations.
- Apply knowledge of global regulations, guidance's, and Corporate and Function standards.
- Lead/assist in the preparation of and support regulatory agency and internal audits.
Vacancy expired!