ASD - Quality Assurance Specialist II (Med Device) in San Diego, CA at Apex Life Sciences

Date Posted: 5/14/2018

Job Snapshot

Job Description


Summary Job Description:

  • Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production.
  • Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
  • Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
  • Facilitates internal training on quality assurance requirements, processes, and procedures.
  • May perform audits and risk assessments.
  • All roles have responsibility for following documented procedures, maintaining records, highlighting areas of nonconformance, adhering to GxP and ensuring audit trails exists. 

Knowledge: 

  • High School Diploma or equivalent. Bachelor’s Degree preferred
  • 2-4 years related experience
  • Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic
  • Knowledge of Quality System Regulations