Quality Engineer - IVDR Risk & eQMS

Tri-Valley Career Center; Hercules (CA); On-site; USD 55,104 - 75,768; Full time

Job summary

Tri-Valley Career Center is seeking a Quality Engineer to support risk management activities for IVDR-related legacy files. The role involves updating risk plans, consolidating hazard analyses, migrating documents into eQMS, and coordinating cross-functional teams to ensure complete and accurate risk profiles.

Strong knowledge of ISO 14971/13485 and GMP concepts is preferred, along with experience using SAP, EtQ or Veeva. This is a project-focused role.

Qualifications

• Bachelor's degree in a related technical or engineering field.
• 2-3 years of experience or equivalent combination of education and experience.
• Knowledge of quality engineering and risk management principles.
• Familiarity with ISO 14971, ISO 13485, MDSAP and FDA CFR Part 820.
• Strong problem solving, coordination and communication skills.

Responsibilities

• Facilitate risk assessments, update risk plans/reports, and consolidate hazard analyses per procedures.
• Coordinate meetings with cross-functional stakeholders to ensure complete and accurate risk profiles; escalate as needed.
• Support migration of product risk management files into the eQMS and ensure metadata accuracy.
• Assess legacy risk documentation against IVDR activities and new guidance.
• Assist with IVDR documentation updates and eQMS migrations.
• Adapt to shifting priorities and support cross-functional teams with patience.
• Act as a self-starter who can work independently with ownership.

Skills

Quality engineering

Risk management

Critical thinking

Teamwork

Communication

Problem solving

Education

Bachelors degree

Engineering discipline

Tools

SAP

EtQ

Veeva

Microsoft Office

Visio

Job description

Tri-Valley Career Center is seeking a Quality Engineer to support risk management activities for IVDR-related legacy files. The role involves updating risk plans, consolidating hazard analyses, migrating documents into eQMS, and coordinating cross-functional teams to ensure complete and accurate risk profiles.

Strong knowledge of ISO 14971/13485 and GMP concepts is preferred, along with experience using SAP, EtQ or Veeva. This is a project-focused role.