MillenniumSoft Inc ยท 11 hours ago
Quality Engineer II, Calibration - Onsite
MillenniumSoft Inc is a company specializing in the medical devices industry, and they are seeking a Quality Engineer II, Calibration. In this role, you will ensure the accuracy and reliability of calibration processes while documenting reports and collaborating with teams to enhance calibration methods and compliance with industry standards.
Staffing & Recruiting
Responsibilities
Develop Procedures: Create and implement calibration procedures for various instruments and systems
Perform Calibrations: Adjust, test, and certify equipment to meet industry standards and specifications
Analyze Data: Examine calibration data, identify deviations, and recommend corrective actions
Troubleshoot: Investigate equipment issues and resolve measurement inaccuracies
Document & Maintain: Keep detailed records, ensuring compliance with quality and regulatory standards (like GMP)
Collaborate: Work with cross-functional teams (e.g., development, quality) to optimize processes
Improve Systems: Participate in projects to enhance calibration methods and equipment
Qualification
Required
Quality Engineer II, Calibration: As a Calibration Engineer at Client, you will play a critical role in ensuring the accuracy and reliability while documenting calibration reports for measurement systems and instruments
You will work closely with department teams to develop calibration protocols, analyze measurement data, and implement continuous improvement strategies to enhance our Baltimore Plant calibration process
Maintaining industry standards to meet performance, quality, and regulatory ISO standards
Utilize specialized Regulatory Asset Management software, specifically Blue Mountain RAM (BMRAM), to track asset data, schedule calibration intervals, and manage work orders
Requires strong analytical skills and often specialized software use
Responsibilities include adjusting equipment, troubleshooting errors, maintaining records, collaborating with teams, and improving calibration processes for reliability and compliance
Develop Procedures: Create and implement calibration procedures for various instruments and systems
Perform Calibrations: Adjust, test, and certify equipment to meet industry standards and specifications
Analyze Data: Examine calibration data, identify deviations, and recommend corrective actions
Troubleshoot: Investigate equipment issues and resolve measurement inaccuracies
Document & Maintain: Keep detailed records, ensuring compliance with quality and regulatory standards (like GMP)
Collaborate: Work with cross-functional teams (e.g., development, quality) to optimize processes
Improve Systems: Participate in projects to enhance calibration methods and equipment