Staff QA Engineer
Assured
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Quality Engineer
Pharmavise Corporation
contract
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Ensure compliance with medical device regulations
- Drive quality excellence across the product lifecycle
- Collaborate with R&D, Manufacturing, Regulatory, and Supplier Quality teams
- Support design control activities and risk management
- Conduct root cause investigations and manage CAPA processes
- Support internal, external, and regulatory audits
Requirements
- 5+ years of experience in medical device quality engineering
- Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related scientific discipline
- Knowledge of FDA QSR, ISO 13485, and ISO 14971
- Hands-on experience in process validation, CAPA, risk management, and audit support
- Familiarity with statistical analysis tools and data-driven decision-making
- Certification in Lean Six Sigma, ASQ CQE, or a similar credential preferred
Benefits
- Health insurance
- Paid time off
- Professional development
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical device quality engineeringprocess validationCAPArisk managementstatistical analysisdata-driven decision-making
Soft skills
collaborationquality excellenceroot cause investigation
Certifications
Lean Six SigmaASQ CQE
