Quality Assurance Consultant

Our medical device client is seeking up to five experienced Quality Assurance Consultants to support a major quality remediation initiative at their Hunt Valley, MD facility.

The site currently has a significant backlog of approximately 400 investigations and 70–100 CAPAs requiring assessment, remediation, and closure. The QA organization consists of approximately 100 personnel, and the selected consultants will work closely with cross-functional teams to strengthen quality systems, complete investigations, and drive effective remediation.

Key Responsibilities

The ideal candidates will have strong experience in aseptic processing, contamination control, investigations, CAPA, and quality-system remediation, including:

• Support and execute deviation and quality investigations, including complex/root-cause investigations.
• Lead and support CAPA development, implementation, and closure.
• Perform quality-system remediation and identify opportunities for sustainable process improvement.
• Develop and implement Contamination Control Strategies (CCS).
• Apply expertise in sterile manufacturing and aseptic processing environments.
• Evaluate and improve environmental monitoring programs and cleanroom controls.
• Support and assess disinfectant efficacy studies.
• Review and evaluate airflow studies and smoke-study assessments.
• Assess facility and utility-related contamination risks.
• Develop, revise, and implement SOPs, procedures, and quality documentation.
• Conduct remediation effectiveness checks and verification to ensure corrective actions are sustainable and effective.
• Collaborate with Quality, Manufacturing, Engineering, Microbiology, Facilities, and other cross-functional teams to resolve quality issues.

Required Qualifications

• 7+ years of Quality Assurance experience within a regulated medical device , or sterile manufacturing environment.
• Strong experience with aseptic processing and contamination control.
• Hands-on experience with deviation investigations, CAPA, and quality remediation.
• Experience working in sterile manufacturing / cleanroom environments.
• Knowledge of environmental monitoring and contamination control practices.
• Experience with facility, utility, airflow, and smoke-study assessments.
• Strong understanding of quality systems, procedures, and remediation effectiveness verification.