Quality Engineer II – Biomedical Device
Pharmavise Corporation
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Draft and manage CAPAs, including conducting detailed root cause analysis
- Perform risk assessments, update Hazard Analyses, and maintain pFMEAs
- Produce clear, detailed, and accurate technical documentation
- Follow technical direction while independently contributing to project deliverables
- Collaborate with cross-functional teams (Quality, Regulatory, Engineering, Operations) to drive quality improvements
- Support a 6-week biomedical device project as a full-time remote contractor (40 hours/week)
- Start ASAP and deliver project-aligned quality systems work
Requirements
- Bachelor’s degree in Biomedical Engineering or related technical discipline (preferred)
- More than 5 years of experience in Quality Engineering within the life sciences industry (strongly preferred)
- Strong technical writing skills for CAPA and compliance documentation
- Hands-on experience drafting and managing CAPAs with root cause analysis
- Experience conducting risk assessments and updating Hazard Analyses
- Experience maintaining and revising pFMEAs
- Excellent communication and interpersonal skills
- Detail-oriented, self-motivated, able to manage workload in a remote environment