Quality Engineer - Hercules, United States - NuWest Group

NuWest Group Hercules, United States

2 weeks ago

Pharmaceutical / Bio-tech

Description

Quality Engineer II - Temporary Position

We are looking for a Quality Engineer II to join our team on a temporary basis. The position is based in either Irvine or Hercules, CA, with 2-3 days required to work on site. This is a 6-month contract with a pay rate of $52 per hour.

As a valuable member of the global PSUR Reporting Team, you will play a crucial role in facilitating business data collection and reporting efforts. Your main responsibilities will include generating periodic product PSUR and post market surveillance reports. This will involve collaborating closely with area subject matter experts to ensure data is collected, documented, and analyzed accurately and in a timely fashion. You will also utilize both local and global systems to gather various post market information such as complaints, field corrective actions, and CAPA data.

How You'll Make an Impact:

Facilitate and generate product Post Market Surveillance (PMS) and PSUR reports, including:
Analyze post market data and review completed reports with business partners
Maintain and support 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 required
Perform other related duties and assignments as necessary

What You Bring to the Team:

Bachelor's degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred
5+ years of experience in a regulated manufacturing industry or an equivalent combination of education and experience
Understanding of GMP and quality system standards as they apply to products manufactured by the company
Knowledge of product post market surveillance requirements for IVD products is a plus
Working knowledge of device/drug/biotech manufacturing processes
Detail-oriented with the ability to multitask
Strong skills in problem-solving, decision-making, time management, organization, communication, leadership, and computer usage
Advanced technical writing and word processing skills
Experience with electronic QMS systems (such as Veeva, EtQ, Trackwise) is advantageous

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