Senior Quality Risk Engineer & QRM SME

BioSpace; North Chicago (IL); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Short-term incentives

Job summary

AbbVie is seeking a Senior Quality Engineer to lead Manufacturing Quality Assurance activities, manage deviations, perform product impact analysis, and drive CAPA in a cGMP environment. You will oversee calibration, quality improvements, and ensure policy compliance at the site.

The role supports the MQA Section Manager and Plant QA Manager, audits commissioning/validation, and reviews critical maintenance while guiding cross-functional teams on risk-based decisions.

Qualifications

• Bachelor's degree in biology, chemistry or engineering.
• 6+ years of manufacturing, quality or engineering experience.
• Strong verbal and written communication skills.
• Knowledge of quality/compliance management and API/Drug manufacturing regulations.

Responsibilities

• Serve as site liaison to support global QRM processes and communicate site feedback.
• Provide QRM oversight for risk assessments (FMEAs) and risk-based decisions.
• Deliver QRM training and assign curricula to site personnel.
• Support Management Review with QRM metrics and mitigation actions.
• Monitor site Quality Risk Management and ensure alignment with global procedures.
• Contribute to validation/qualification decisions as a QRM SME.
• Ensure adherence to quality goals and regulatory requirements across quality areas.

Skills

Quality management

Regulatory compliance

Risk assessment

Quality documentation

Cross-functional collaboration

Education

Bachelor's degree in Biology/Chemistry/Engineering

Job description

AbbVie is seeking a Senior Quality Engineer to lead Manufacturing Quality Assurance activities, manage deviations, perform product impact analysis, and drive CAPA in a cGMP environment. You will oversee calibration, quality improvements, and ensure policy compliance at the site.

The role supports the MQA Section Manager and Plant QA Manager, audits commissioning/validation, and reviews critical maintenance while guiding cross-functional teams on risk-based decisions.