Post Market Quality Engineer II

4 weeks ago

Irvine, United States Radiant Systems Full time

We are hiring for one of our Major Medical Device Clients in Irvine, CA.

Client: Major Medical Device Client Title: Post Market Quality Engineer II Location: Irvine, CA Duration: 6+ Months

Pay Rate: $50-$52/ Hr on W2

M-F 8am-5pm Hybrid in Hercules 2-3 days on site

Description: • 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.

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 completed 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. • 5+ 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 Client. • 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.

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