HYBRID: Quality System Specialist II

The Quality System Specialist will support IVDR compliance initiatives by updating and consolidating legacy product technical documentation, risk management files, and Design History Files (DHFs). Responsibilities include conducting risk assessments, updating hazard analyses and risk reports, identifying documentation gaps, facilitating cross-functional reviews, and supporting migration of product files into the eQMS system. The role requires working independently in a fast-paced, changing environment while ensuring accuracy, completeness, and regulatory compliance.

Do you have experience in Visio?, Do you have a Associate’s degree?, * Associate degree in Biology, Chemistry, Engineering, or related field.

• 2+ years of experience in a regulated manufacturing environment.
• Knowledge of GMP and quality standards such as ISO 13485, MDSAP, and FDA 21 CFR 820/210/211.
• Experience with risk management, technical documentation, and DHF/eQMS activities.
• Proficiency with Microsoft Office, Excel, and Visio.
• Strong organizational, communication, and project coordination skills., * Experience with IVDR, product design and development, and risk management.
• Familiarity with Salesforce, Veeva, EtQ, and/or SAP.
• Knowledge of medical device, pharmaceutical, or biotechnology manufacturing processes.

(part of The Adecco Group) 3.73.7 out of 5 stars Hercules, CA 94547 $35 - $40 an hour - Contract