Senior Calibration-Metrology Engineer

Sira Consulting, an Inc 5000 company; Houston (TX); On-site; USD 120,000 - 155,000; Full time

Job summary

Sira Consulting is seeking a Senior Metrology / Calibration Remediation Engineer to lead calibration program remediation in a regulated manufacturing environment. You will drive gap assessments, measurement uncertainty implementation, calibration interval optimization, and fitness-for-use evaluations while collaborating with cross-functional teams.

Responsibilities include audits, procedures, training, and ensuring compliance with ISO 13485, ISO 17025, and CFR standards, while improving

Qualifications

• Minimum 10+ years of metrology/calibration in regulated industries.
• Strong knowledge of dimensional metrology, MSA, measurement uncertainty, traceability.
• Familiarity with ISO 13485, ISO 17025, 21 CFR Part 820/QMSR, Part 11, and Gage R&R.
• Experience with OOT/OOC, CAPAs, risk assessments, and audits.

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 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.

Skills

Metrology expertise

Calibration principles

Measurement uncertainty

MSA

Gage R&R

Data analysis

Risk-based decision making

Tools

ProCal V5

Siemens Teamcenter

Minitab

Job description

need minimum 15 years of relevant experience, regulated industries or medical devices, Ultrasonic Welders and CMMS,

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.