Our client, a mid sized SaMD, is seeking an experienced Design Quality Engineer to own a number of NPD activities.
The role offers a fast-paced team environment where you can make an impact in a particularly vulnerable demographic.
Responsibilities
Lead Design control activities for a number of their NPD including DHF and DFMEA
Write brand new risk management files
Develop new V&V testing
Support with cybersecurity activities
Be part of a team supporting wider range quality activities including post marketing, CAPAs and audit
Qualifications
Experienced within design/risk activities for SaMD (i.e. both a ISO***** and IEC ***** background)
Hands on Design History File (DHF) writing alongside Design control activities including V&V planning, DFEMA and risk management writing
Worked in Agile environments and SDLC
Ideal candidates would have worked with cybersecurity standards (ISO *****)
Bachelor's degree required
Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Quality Assurance, Manufacturing, and Design
Industries: Medical Equipment Manufacturing and Software Development
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