Device Tester V in San Diego, CA at APEX Systems

Date Posted: 1/14/2020

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    San Diego, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    1/14/2020

Job Description

Job #:  1038930
Our client, a leader in medical devices, is seeking a Device Tester to join their 1st shift team. 

Must Haves: 
  • Solid laboratory skills 
  • Acts independently to determine methods and procedures on current assignment 
  • Committed to project goals 

Summary 

Under general supervision, the scope of this position is responsible for monitoring product quality through testing and observation. Additionally, this position consists of the operation of moderately complex semi-automated equipment. 

Tasks and responsibilities: 
  • Oversee a single shift in the device testing laboratory. 
  • Responsible for monitoring and reporting shift outcome. 
  • Responsible for training and documentation.
  • Ensure completeness and accuracy of manufacturing documents. 
  • Responsible for retrieving, compiling, and reviewing data associated with device testing.
  • Ensure inventory accuracy of all testing related materials.
  • Complete testing in support of production goals, related troubleshooting, and on-going projects.
  • Ensure compliance to all applicable to FDA, ISO, OSHA, etc. regulations.
  • May schedule testing of on-going process and product monitoring activities including real-time stability protocols.
  • May be responsible for monitoring product quality.
  • May be responsible for laboratory equipment maintenance and calibration in-service dates. 
  • May be responsible for adequate laboratory supplies and testing materials inventory levels. 
  • Acts independently to determine methods and procedures on new assignments and may provide guidance and oversee the activities of other non-exempt employees. 
  • Provides immediate supervision or assigns tasks to a unit or group of employees. 
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA and other regulatory agencies. 
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities. 


Preferred educational background: 
  • Typically requires a high school diploma or equivalent and 4-6 years related experience. 

Preferred experiential background: 
  • Working understanding of FDA, ISO, OSHA and any other applicable regulatory agency regulations. 
  • Solid laboratory skills 
  • Fundamental bio-hazardous material handling and use competency. 
  • Working knowledge of Global Statpak. 
  • Detailed product device testing knowledge. 
  • Basic understanding of manufacturing goals. 
  • Able to review the work of other device testers and determine next actions, with exception. 

 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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.

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