Overview
Quality Engineer Jobs in San Francisco, California, USA at Cypress HCM
This range is provided by Cypress HCM. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$45.00/hr – $52.00/hr
Quality Engineer I
As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating periodic product PSUR / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate manner. The candidate will use local and global systems to collect various post market information such as complaint, field corrective action and CAPA data.
In addition, the QE will work with subject matter experts to analyze product related data and document conclusions of the review activities.
This position is eligible for a hybrid schedule in Irvine or Hercules, CA.
How You’ll Make An Impact:
Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports including:
Analysis of post market data and reviewing completed reports with business partners.
Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance.
Maintain, archive and complete controlled quality records.
Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners.
Facilitate and/or chair local/regional PMS Board meetings.
Support various QMS and PMS projects (local and global) as needed.
Support internal/external audits as needed.
Perform other related duties and assignments as needed.
What You Bring:
Bachelor’s degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred.
3+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.
Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad.
Understanding of product post market surveillance requirements for IVD products a plus.
Working knowledge of device/drug/biotech manufacturing processes.
Detail-oriented and ability to multitask.
Problem solving, decision making, time management, organization, communication, leadership, and computer skills.
Advanced technical writing and word processing skills.
Experience with electronic QMS systems (i.e. Veeva, EtQ, Trackwise) a plus.
Long term contract (can convert to FTE)
Seniority level
Associate
Employment type
Contract
Job function
Engineering and Quality Assurance
Industries
Medical Practices and Biotechnology Research
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Title: Quality Engineer
Company: Cypress HCM
Location: San Francisco, California, USA
Category: Quality Assurance – QA/QC, Engineering
