The Quality Engineer will oversee and support metrology operations, focusing on maintaining and improving measurement systems to ensure compliance with cGMP standards.
Key Responsibilities:
Support quality engineering in design, validation, and implementation of measurement systems.
Develop and maintain SOPs, measurement methods, and test reports.
Provide technical guidance and training to staff on measurement protocols and FDA/cGMP compliance.
Conduct internal audits, data integrity reviews, and assist with regulatory audits.
Manage and document system processes and ensure accurate calibration of equipment.
Participate in strategic planning for project development.
Requirements:
Bachelor's degree in engineering or a related field.
4+ years of experience in CMM programming, SolidWorks, and quality assurance in a medical device environment.
Familiarity with FDA, cGMP regulations, and advanced measurement tools like CT scanning.
Strong technical writing, documentation, and communication skills.
Preferred:
ASQ certifications and proficiency in Microsoft Office.