Quality Engineering S

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

Day-to-Day 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 (3-5 years, mid-level)
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 bachelor's degree
Certifications: GAMP 5, Audit, CSQE (all are a plus)
Experience Level: Mid (3-5 years)
Industry Experience: Required in medical devices

Required Skills : CSV experience in medical devices and 21 CFR (3-5 years, mid-level) GAMP 5 experience Experience in medical device manufacturing and operations
Basic Qualification :
Additional Skills :

Background Check : Yes

Drug Screen : Yes

Notes :
Selling points for candidate :
Project Verification Info :
Candidate must be your W2 Employee :No
Exclusive to Apex :Yes
Face to face interview required :Yes
Candidate must be local :Yes
Candidate must be authorized to work without sponsorship ::No
Interview times set :Yes
Type of project :
Master Job Title :LABENG
Branch Code :