Quality Engineer III in San Francisco, CA at APEX Systems

Date Posted: 8/15/2019

Job Snapshot

Job Description

Job #:  979983

 
Our client is a leader in women’s health through genetic screenings. They are transforming therapeutics worldwide. 
POSITION SUMMARY
Quality Engineer III supports the quality system processes of the CLIA laboratories and activities associated with CE-IVD kits and software.  The QE III works with QE Manager/QA Director to address supplier issues, nonconformances and corrective actions that impact the CLIA laboratory operations. This position will also represent QA on product development projects.
PRIMARY RESPONSIBILITIES
  • Support internal and external audits (CLIA/CAP, ISO 13485, customer)
  • Responsible for CAPA, Deviation, Change Requests and Nonconformance investigation and reporting
  • Write/revise procedures and forms; submit to Document Control and assist with training as needed
  • Perform statistical analysis/hypotheses testing (AQL’s etc) as required
  • Support Quality systems compliance to CLIA, FDA QSR, ISO 13485, and HIPAA
  • Participate in the management of Approved Suppliers
  • Follow established company standard operating procedures and good documentation practices
  • Review manufacturing/QC batch records
  • Other duties as assigned

QUALIFICATIONS
  • Position requirements are a B.S. or equivalent in science, engineering or related field
  • At least 6 years of experience in medical diagnostic, CLIA laboratory, or Life Sciences industry; 3 years experience in a quality role
  • Audit experience – internal audits, third party audits and/or regulatory audits
  • American Society of Quality certifications (CQE) preferred FICATIONS

KNOWLEDGE, SKILLS, AND ABILITIES
  • Knowledge of CLIA/CAP regulations, ISO 13485 standard and/or FDA QSRs (21 CFR 820)
  • Computer skills (MS Word, Excel, PowerPoint, etc.)
  • Good technical writing and communication skills
  • Independent worker, a self-starter with strong organizational and planning skills 
  • Has an ability to be productive and successful in an intense work environment

Preferred skills:
  • Hands on experience with DNA Isolation and Purification, PCR, Cell Culture, Sequencing, Bioinformatics etc.
  • Demonstrated good judgment, excellent attention to detail, excellent written, verbal communication and interpersonal skills are desired with the ability to be flexible and collaborate on multiple projects

PHYSICAL DEMANDS AND WORK ENVIRONMENT
  • Duties typically performed in an office setting
  • Must be able to sit or stand for long periods of time

 
 
 
 
 
 
 
 
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 844-463-6178-6178.