Quality Assurance Specialist
DeepHealth
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Salary
💰 $117,000 - $147,000 per year
About the role
- Support DeepHealth products and product development, along with the Quality Management System throughout the organization.
- Collaborate cross-functionally to support and guide product development.
- Work cross-functionally and within the team to support the Quality processes, such as QMS training, complaint and CAPA management.
Requirements
- Bachelor’s degree in relevant field (or equivalent experience, i.e. Associates Degree with 3 years of experience)
- Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
- Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304 preferred.
- Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56, preferred but not required.
- 5 - 8 years working in a regulated industry (FDA and Software as a Medical Device preferred)
- Participation in regulatory audits a plus
- Excellent written and oral communication skills.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
FDA Quality System Regulations21 CFR 1121 CFR 820EU Medical Device Regulation (MDR)ISO 13485ISO 14971IEC 62304pre-market clinical studiespost-market clinical studiesregulatory audits
Soft Skills
excellent written communicationexcellent oral communication