Quality Engineer

Quality Engineer will support quality and compliance activities within a regulated Medical Device environment, applying Quality Engineering principles and Six Sigma / Lean tools to drive continuous improvement and implement system or process modifications.

Requirements

• Execute equipment (testing) validations in a Medical Device environment, including protocol development, execution, and final reports.
• Perform and support test method validations to ensure compliance with intended use and regulatory requirements.
• Support and/or lead quality investigations, including deviations, nonconformances, root cause analysis, and documentation.
• Support the development, execution, and effectiveness verification of CAPAs.
• Review, revise, and approve controlled documents (SOPs, protocols, reports, forms) in accordance with document control procedures.
• Apply Quality Engineering principles and Six Sigma / Lean tools to design, evaluate, and implement system or process improvements.
• Develop, implement, and maintain Sampling Plans based on risk and statistical rationale.
• Support and execute Change Control activities, including impact assessments and cross-functional coordination.
• Create, review, and maintain pFMEA documentation to identify, assess, and mitigate process risks.
• Ensure compliance with GMP, ISO, and applicable regulatory requirements.