Quality Engineer Manager

About the role

The Quality Engineer Manager oversees the daily activities for Quality Engineering functions. This role ensures cGMP regulations and internal quality standards while supporting both development and commercial programs.

Responsibilities

• Oversee the Environmental Monitoring and Cleaning Validation program
• Provide quality oversight for all process, equipment and instrument validation and/or verification protocols and reports
• Work closely with cross-functional stakeholders to ensure quality oversight for Computer Systems Validation of all software systems facility wide (i.e., Ignition, Empower. NetSuite)
• Trend CPP and CQA parameters to identify trends and work with operations to identify corrective actions as appropriate
• Oversee Risk Management program and conduct risk assessments and impact assessments for change controls as needed
• Serve as Subject Matter Expert within business on regulatory and compliance requirements for all areas of responsibility
• Oversee review and release of batch records

Requirements

• B.S. Degree in Engineering or Science
• 8-10 years of industry experience
• Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, and / or Six-Sigma
• CQE preferred
• Technical skills: Risk Management, Computer System Validation, Cleaning validation and equipment qualification experience, Proficient in Change control process, Working independently to pull and trend data and write reports