Risk & Quality Systems Specialist II (IVDR)

Tri-Valley Career Center; Hercules (CA); On-site; USD 48,216 - 60,614; Part time

Job summary

Bio-Rad is seeking a qualified professional to support risk management activities, update hazard analyses, and coordinate cross‑functional input for comprehensive risk profiles. The role includes migrating risk files to the eQMS, ensuring metadata accuracy, and addressing gaps relative to IVDR guidance while maintaining adherence to GMP/ISO standards.

The position requires an associate degree and 2+ years in regulated manufacturing or equivalent experience, with strong organizational and

Qualifications

• Associate degree in Biology, Chemistry, Engineering or related field.
• 2+ years experience in regulated manufacturing or equivalent education and experience.
• Knowledge of GMP/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
• Familiarity with device/drug/biotech manufacturing processes.
• Detail‑oriented with strong organizational, project management, multitasking abilities.
• Skills in decision making, time management, communication, and computer use.
• Proficient in Microsoft Office, Visio, and Excel.
• SalesForce, Veeva, EtQ and/or SAP experience are desirable.
• Experience in product design and development and risk management a plus.

Responsibilities

• Facilitating risk management assessments, updating risk plans and reports, and consolidating and updating product system hazard analysis files in accordance with established company procedures and applicable standards.
• Coordinating and facilitating meetings with cross‑functional stakeholders to gather information for risk profiles and identify new risks, escalating to Management as needed.
• Supporting migration of product risk management files into the eQMS system and ensuring accurate metadata and linking to legacy DHF binders.
• Assessing legacy technical and risk documentation and identifying gaps relative to IVDR transitional activities vs new guidance.
• Supporting other IVDR‑related technical documentation updates and gap assessments, including migration into eQMS (document scanning, etc.).
• Working in a dynamic environment with cross‑functional teams, showing ownership and accountability for tasks.

Skills

Detail-oriented

Organizational skills

Project management

Multitasking

Decision making

Time management

Communication

Computer literacy

Education

Associate degree

Tools

Microsoft Office

Visio

Excel

SalesForce

Veeva

EtQ

SAP

Job description

Bio-Rad is seeking a qualified professional to support risk management activities, update hazard analyses, and coordinate cross‑functional input for comprehensive risk profiles. The role includes migrating risk files to the eQMS, ensuring metadata accuracy, and addressing gaps relative to IVDR guidance while maintaining adherence to GMP/ISO standards.

The position requires an associate degree and 2+ years in regulated manufacturing or equivalent experience, with strong organizational and