Quality Engineer
Quality Engineer
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1 Vacancy
Job Description
Job Title: Software Quality Engineer (SQE)
Number of Positions: 1
Duration: 12 months
Work Location: Onsite Hybrid (3 days a week)
Start Date: January
Project Details:
- Scope of Work:
- Serve as SQE working independently on supporting warehouse information
- Review test plans and requirement documents
- Perform approvals on documents to meet applicable regulations (21 CFR)
- Support validation on warehouse systems
- Support equipment decommissioning
- Collaborate on testing plans and approvals
- Work with supplier quality and commercial quality teams
- DaytoDay Responsibilities:
- Review test plans and requirement documents
- Perform approvals to meet regulations (21 CFR)
- Support equipment decommissioning
- Collaborate on testing plans and approvals
- Work with supplier quality and commercial quality teams
Requirements:
- CSV experience in medical devices and 21 CFR (35 years midlevel)
- GAMP 5 experience
- Experience in medical device manufacturing and operations
Bonus Requirements:
- GAMP 5 certification
- Onsite (local resource)
- CSQE certification
- Auditor certification
Additional Requirements:
- Soft Skills/Company Culture: Team environment collaboration independent communication
- Education: Engineering/science/technical bachelors degree
- Certifications: GAMP 5 Audit CSQE (all are a plus)
- Experience Level: Mid (35 years)
- Industry Experience: Required in medical devices
Required Skills : CSV experience in medical devices and 21 CFR (35 years midlevel) GAMP 5 experience Experience in medical device manufacturing and operations
Employment Type
Full Time
