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Quality Engineer
Quality EngineerMy3Tech Inc • Jacksonville, FL, United States
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Quality Engineer

Quality Engineer

My3Tech Inc • Jacksonville, FL, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.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
  • 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 :

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