Sr Quality Engineer, New Product Development - IVD
14971, IEC 62304, and 21 CFR 820) and company policies. Collaborates, sets up meetings, determines action plans, performs...
14971, IEC 62304, and 21 CFR 820) and company policies. Collaborates, sets up meetings, determines action plans, performs...
in one of the following software languages: C, C++, Python, or Rust Experience designing products for IEC 60601 compliance Pay...
of common information security management frameworks, such as ISO/IEC 27001, and NIST. Excellent written and verbal...
including knowledge of standards such as IEC 62304, ISO 14971. Understanding of Cyber Security concepts is strongly preferred...
networks compliant with ISA/IEC 62443 standards. Be the SME for our Shop Floor Network (Manufacturing division Core...
. Preferred Qualifications Expert knowledge of Medical Product verification, IEC-62304 and FDA guidance in a technical...
Engineering team and software development activities using Agile/Scrum methodology and consistent with the IEC 62304 standard... in accordance with ISO 14971 Maintain and prepare software documentation in compliance with IEC 62304 and ISO 13485 Requirements...
Software Engineering team and software development activities using Agile/Scrum methodology and consistent with the IEC 62304... risk management file in accordance with ISO 14971 Maintain and prepare software documentation in compliance with IEC 62304...
with control hardware and writing design specifications. Familiarity with functional safety standards (e.g., IEC 61508, IEC61511...
9001:2015 and ISO/IEC 27001:2013 certified small business and appraised at CMMI Level 3 (with SAM) for Services. We possess...