Quality Engineer II

Job Title: Quality Engineer II – Temporary (Hybrid Position: Irvine – 9400 Jeronimo)

Schedule: Monday to Friday, 8:00 AM to 5:00 PM Hybrid 2-3 days on site

Duration: 6 months, potential to extend/ convert

Salary: Up to $52 per hour

As part of the global PSUR Reporting Team, the Quality Engineer II will play a crucial role in facilitating business data collection and reporting efforts, focusing on generating periodic product PSUR (Periodic Safety Update Report) and post-market surveillance reports. This role requires collaboration with subject matter experts to ensure accurate and timely data collection, documentation, and analysis.

Key Responsibilities:
Facilitate and generate product Post Market Surveillance (PMS) and PSUR reports, including:
– Analyzing post-market data and reviewing completed reports with business partners.
– Maintaining and supporting databases and systems for tracking various Quality Management System (QMS) activities related to post-market surveillance.
– Managing and archiving controlled quality records.
– Coordinating PMS and post-market performance follow-up (PMPF) deliverables with internal business partners.
– Facilitating and/or chairing local/regional PMS Board meetings.
– Supporting various QMS and PMS projects (local and global) as needed.
– Supporting internal/external audits as required.

– Bachelor's degree or equivalent in a related life science/technical/engineering discipline preferred.
– 5+ years of experience in a regulated manufacturing industry or equivalent combination of education and experience.
– Understanding of Good Manufacturing Practices (GMP) and quality system standards as they apply to products manufactured by Bio-Rad.
– Knowledge of product post-market surveillance requirements for In Vitro Diagnostic (IVD) products is a plus.
– Familiarity with device/drug/biotech manufacturing processes.
– Experience with electronic QMS systems (e.g., Veeva, EtQ, Trackwise) is advantageous.

How You'll Make an Impact:
Joining our team means contributing to critical efforts in product safety and quality assurance, working collaboratively with global teams and utilizing your expertise to ensure compliance and excellence in post-market surveillance activities.

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