Senior Calibration-Metrology Engineer

The Senior Metrology / Calibration Remediation Engineer is responsible for leading calibration and metrology program remediation initiatives within a regulated manufacturing environment. The role drives gap assessments, measurement uncertainty implementation, calibration interval optimization, and fitness-for-use evaluations to ensure compliance with quality and regulatory requirements. The engineer collaborates with cross-functional teams to enhance metrology processes, standardize calibration methodologies, and resolve equipment-related compliance risks. Responsibilities include conducting risk-based assessments, supporting audits, developing technical procedures, and delivering competency-based training programs. The position plays a key role in improving measurement system reliability, operational efficiency, and overall product quality.

Key Responsibilities:

Perform gap assessments of calibration and measurement management systems and drive remediation activities to align with corporate quality procedures and industry standards.

Prepare and standardize calibration procedures, measurement uncertainty methodologies, calibration interval practices, and metrology-related SOPs.

Establish processes for measurement uncertainty analysis, tolerance evaluation, guard banding, and fitness-for-use assessments using methodologies such as PAR, TMU, and RSS Guard banding.

Perform OOT/OOC investigations, product impact assessments, criticality reviews, calibration interval optimization, and risk-based decision making using statistical analysis and objective evidence.

Evaluate and improve calibration methodologies for manufacturing and inspection equipment, including ultrasonic welders, vision systems, automated assembly cells, packaging equipment, and dimensional metrology systems.

Collaborate with Engineering, Manufacturing, Validation, Laboratory Operations, and Quality teams to implement sustainable metrology process improvements and ensure regulatory compliance.

Create competency-based training programs, establish qualification requirements for metrology personnel, and support internal, customer, and regulatory audits.

Qualifications:

Minimum 10+ years of experience in metrology, calibration, or remediation programs within regulated industries such as medical devices, pharmaceuticals, aerospace, or similar manufacturing environments.

Strong technical expertise in dimensional metrology, measurement system analysis (MSA), calibration principles, measurement uncertainty, traceability, tolerance analysis, and calibration interval optimization.

Comprehensive knowledge of quality and regulatory standards, including ISO 13485, ISO 17025 principles, 21 CFR Part 820/QMSR, 21 CFR Part 11, and Gage R&R methodologies.

Preferred experience with ProCal V5, Siemens Teamcenter, medical device manufacturing environments, and ISO 9001, ISO 10012, or ANSI/NCSL Z540 standards.

Proficiency in statistical analysis tools such as Minitab and the ability to analyze calibration data, performance trends, and reliability metrics.

Experience in conducting fitness-for-use evaluations, OOT/OOC investigations, risk assessments, CAPAs, deviations, and product impact assessments.