Nemedio is looking for a mid level Software Validation Engineer who has successfully assisted in the validation of Quality Management and other regulated software in the Medical Device and/or Pharmaceutical industries to join our growing team. You’ll be involved in assisting our teams and our clients with input on how to build the best compliant products out there.
You have 4-7 years experience with software validation in a FDA regulated environment. You’ve helped elicit User Requirements and Software Requirements, written validation protocols and reports, recorded and investigated deviations, authored quality documents (SOPs, WIs, templates etc.) from scratch. You understand how to apply risk management principles to software and may even be able to help guide our clients with best practices for product risk management and validation activities. That being said, you are also open to new ways of looking at quality activities and aren’t shy about challenging the old ways of thinking, as long as the new way is still compliant. You have worked closely with engineering teams and know how to deal with the unique challenges that arise when trying to get engineers to do “regulatory and quality stuff.”
You have working knowledge of most of these buzzwords, and are probably an expert in a handful of them:
- 21 CFR Part 820 / ISO 13485
- 21 CFR Part 210/211
- 21 CFR Part 11
- Design Verification and Validation
- Software Validation
- GAMP5
- ISO 14971
- Software Development for Medical Devices per IEC 62304
- Human Factors Engineering per ISO 62366
- Agile software development