SR QA Risk Management Engineer

Responsibilities

• Develop, implement, and maintain quality risk management policies, procedures, and work instructions aligned with applicable industry regulations and standards.
• Establish and manage a site-wide Quality Risk Register to identify, assess, prioritize, mitigate, and monitor business and operational risks.
• Serve as the Quality Risk Management subject matter expert (SME) and provide guidance on risk assessment methodologies including FMEA, FTA, HACCP, PHA, and related tools.
• Support risk-based decision-making for deviations, investigations, CAPAs, change controls, validation activities, and engineering projects.
• Facilitate risk assessments associated with manufacturing processes, equipment qualification, facility modifications, and operational improvements.
• Author, review, and maintain risk management documentation and associated records.
• Prepare risk management metrics, trend analyses, and management review reports.
• Collaborate with cross-functional stakeholders to integrate risk management principles into daily operations and strategic initiatives.
• Lead risk assessment workshops, training programs, and coaching sessions to strengthen organizational risk awareness and competency.
• Support internal audits, customer audits, and regulatory inspections as the quality risk management representative.
• Monitor regulatory developments and industry best practices and recommend updates to risk management processes as needed.
• Ensure risk management activities are effectively integrated within the Quality Management System (QMS).

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Quality, or a related technical discipline; advanced degree preferred.
• Minimum of 7 years of experience in Quality Assurance, Quality Risk Management, Compliance, Validation, or a related function within a regulated manufacturing environment.
• Demonstrated experience developing and implementing risk management programs, policies, procedures, and assessment tools.
• Strong knowledge of quality systems, risk management methodologies, and applicable regulatory requirements.
• Hands-on experience conducting and facilitating risk assessments using tools such as FMEA, FTA, HACCP, and Preliminary Hazard Analysis (PHA).
• Experience supporting manufacturing operations, quality systems, engineering projects, and validation programs.
• Excellent written and verbal communication skills with the ability to effectively communicate technical information to both technical and executive audiences.