Description

You will apply Quality Engineering principles to optimize systems and processes against strategic and regulatory needs.

Responsibilities

• Develop and optimize systems and processes using Quality Engineering principles, tools, and techniques.
• Provide support for customer, regulatory, and internal audits.
• Perform investigations using root cause analysis and risk assessment to determine corrective action.
• Lead, coordinate, and maintain validations for all departments, including the Calibration Program and Environmental Monitoring Program.
• Conduct internal and supplier audits, monitoring compliance with ISO and FDA Quality System Regulation standards.

Required Skills

• Bachelor's degree in Engineering or a related field.
• Minimum 3+ years of proven experience as a Quality Engineer.
• 3+ years of experience in Pharma or Bio environments.
• Strong background in root cause analysis and investigation.
• Experience working in an assembly or cleanroom environment.
• Experience maintaining SOPs and the Quality Management System.
• Experience collecting, reviewing, and interpreting data for trend reports and complaints.

Preferred Skills

• Knowledge of ISO 9001 and other regulatory requirements.
• Familiarity with ERP tools like ETQ or Epicor.
• Certification in Quality Engineering or Lean Six Sigma.

Key Skills

Education

Bachelor's degree