Sr. Quality Engineer
Sr. Quality Engineer
Posted on :
13-08-2025
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1 Vacancy
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Job Description
Responsibilities:
- Lead quality engineering activities for new hardware/software medical device development including design control and risk management.
- Develop and maintain Risk Management File (RMF) dFMEA pFMEA hazards analysis and risk reports.
- Review/approve Design History File (DHF) design inputs/outputs verification & validation plans test protocols and reports.
- Provide statistical guidance for design verification validation and test method validation.
- Act as SME for software quality including code reviews cybersecurity software BOM and AI/cloud-based solutions.
- Support design transfer production anomalies CAPA closure and quality system updates based on regulations.
- Strong knowledge of FDA CFR 820 ISO 13485 ISO 14971 IEC 60601 IEC 62304 IEC 62366.
- Experience in medical device hardware software and electromechanical systems.
- Skilled with statistical tools (Minitab) Microsoft Office Adobe Acrobat.
- ASQ CQE and/or Six Sigma Green/Black Belt preferred.
- AI SaMD AAMI TIR45 and cloud infrastructure experience a plus.
- B.S./M.S. in Engineering (biomedical software electrical or related).
Employment Type
Full-time
Key Skills
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