Quality Specialist (Product Quality Surveillance) in San Diego, CA at Apex Life Sciences

Date Posted: 9/26/2018

Job Snapshot

Job Description

Our client, a leader in diagnostics, is seeking a Quality Specialist (Product Quality Surveillance) 


  • Assist in management of a CAPA project, which involves review of customer communications and complaint handling
  • Coordinate CAPA-related activities across multiple areas/groups
  • Summarize, track, and report on analysis of data
  • Carry out duties in compliance with established business policies
  • Demonstrate commitment to the effectiveness of the division Quality Management System per ISO, FDA, and other regulatory agencies
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices
  • Perform other duties & projects as assigned

Qualifications (essential):

  • Bachelors degree in related field (Science or engineering preferable)
  • 3-5 years working in a regulated medical device complaint management function
  • 3-5 years experience as CAPA Coordinator, Quality Engineer, or Quality Analyst in regulated medical device industry
  • Project Management experience
  • Strong background in complaint management process definition and compliance discipline
  • Solid knowledge of regulations related to medical device complaints in accordance with 21 CFR Part 820.198 and ISO 13485
  • Experience working in electronic complaint management systems
  • Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness
  • Excellent computer skills including all MS Office applications- especially Excel to manage data

Please send resumes to mmiller@apexlifesciences.com


EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.