Quality Engineer (Diagnostics)

Location
San Carlos, California
Salary
115,000
Posted
May 21, 2019
Ref
955917
Required Education
Bachelors Degree
Position Type
Full time

Quality Engineer Opportunity.

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