Software Quality Engineer in San Diego, CA at Apex Life Sciences

Date Posted: 8/9/2018

Job Snapshot

Job Description


Our client, a leader in NGS technology, is seeking a Software Quality Engineer. 

Duties:

  • The Software Quality (SQA) Engineer is part of the Quality Department and provides support to software development teams to ensure that the company's product software is designed in accordance with policies and procedures.
  • Processes meet the requirements for DIAGNOSTIC MEDICAL DEVICES (IVDs), requirements for products to be deployed in LABORATORY DEVELOPED TESTS (LDTs), RESEARCH USE ONLY diagnostic (RUO)  products, as well as diverse other applied genomic (e.g. forensics, agriculture). 
  • This is not a software testing position.


Skills:

  • Expert knowledge of product development, and specifically software development (SDLC) processes, Software Engineering Best Practices Design Controls, Risk Management, Verification and Validation
  • Foundational Understanding of the application of regulations and standards (21CFR 820, IVDD/IVDR, ISO 13485, ISO 14971, IEC62304).
  • Experience with Clinical Trials/Evaluations, GxP, Auditing and CROs is a plus.
  • Experience with post market activities (complaint handling / failure investigations) relative to software
  • Comprehend software technical reports and specification documents.

Preferred:

  • Desired Quality/Regulatory certifications (CSQE, CQE, CQM, RAC)
  • ASQ certification desired
  • Hands-on experience with Next Generation Sequencing consumables and chemistry.
  • Hands-on experience with Software (e.g. Bio-Informatics) used in Next Generation Sequencing products

Education:

  • Bachelors degree in Computer Science, Software Engineering, Bio-Informatics, Biomedical or related discipline. Graduate degree preferred
  • 10 years experience in (software) quality engineering role in a medical device / IVD company environment.

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 employeeservices@apexsystemsinc.com or 844-463-6178.

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 employeeservices@apexsystemsinc.com or 844-463-6178.




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