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Quality Specialist - Quality Specialist 2- - San Diego CA

  • Location: San Diego
  • $ Salary: US$30 - US$36 per hour per hour
  • Job Type:Contract

Posted 4 months ago

  • Sector: Engineering, Life Sciences
  • Contact: Ben Upton
  • Duration: 6 months
  • Start Date: ASAP
  • Expiry Date: 01 July 2023
  • Job Ref: JN -042023-478728

A leading biotech company are searching San Diego for a Quality Specialist 2 on a 6 month contract basis! They are looking for someone with Document Control Experience as well as, Quality assurance experience in all aspects of device/diagnostic quality systems. The ideal candidate will be familiar GDP, FDA Quality systems regulations and ISO standards

Hourly pay Range: $30-36 per hour

Some Key Responsibilities:

  • Manage the document control program (change request/change orders) as well as suggest and implement improvements to existing process
  • Monitor change activities such as review/approval/implementation and be able to resolve issues of varying complexity
  • Interface with internal and external customers to convey requirements and resolve issues to drive efficient and effective process
  • Write, edit, review and maintain procedural documentation including, but not limited to, department policies, procedures and guidance documentation
  • Perform trending analysis (Quality Metrics) on an as needed basis, including using statistical process control methods
  • May assist in the investigation and resolution of nonconforming events and CAPA projects

Some Key Requirements:

  • 2-4 years of direct work experience in QA, including all aspects of device/diagnostic quality systems
  • Managing document control systems (electronic preferred) is required
  • Experience working in an ISO 13485 or CAP/CLIA regulated environment
  • Excellent problem solving and analytical skills Effective interpersonal and communication skills and capable of supporting cross-functional project goals
  • An understanding of GDP, FDA Quality System Regulations, CLIA and/or ISO Standards (ISO 13485 and ISO 14971) is a plus, Quality engineering experience is a plus

Educational Requirements:

  • HS Diploma/GED

If you feel like you are the right person for the job, please apply with a recent resume to be considered!