Sr. Quality Engineer-Metrology

Key Responsibilities

• Lead or support remediation of metrology and calibration programs in regulated industries (medical device, pharmaceutical, aerospace, etc.)
• Conduct gap assessments, identify compliance deficiencies, and develop sustainable remediation plans
• Address audit observations, CAPAs, and regulatory findings related to calibration systems
• Improve calibration compliance, reduce overdue calibrations, and strengthen calibration governance
• Apply deep knowledge of dimensional metrology, measurement system analysis, and calibration principles
• Demonstrate strong understanding of measurement uncertainty, tolerance analysis, traceability, guard banding, and calibration intervals
• Perform fitness-for-use evaluations and apply decision rules (PAR, TMU, Z%, RSS guardbanding)
• Support calibration and troubleshooting of equipment such as: Ultrasonic welders, pneumatic presses, vision systems, automated assembly cells, injection molding equipment, packaging equipment (FFS, band sealers, shuttle sealers), CMMs, force/torque systems, leak and flow instruments, environmental monitoring equipment
• Evaluate out-of-tolerance (OOT) conditions and determine product/validation impact
• Ensure compliance with applicable standards and regulations, including: ISO 13485, 21 CFR Part 820 / QMSR, ISO 17025 principles, 21 CFR Part 11 (as applicable), Gage R&R and MSA methodologies
• Author and revise calibration procedures, deviations, CAPAs, impact assessments, and risk assessments
• Support internal, customer, and regulatory audits
• Independently assess calibration events using risk-based methodologies
• Conduct OOT/OOC impact assessments and analyze historical calibration data
• Apply statistical tools (Minitab or equivalent) to evaluate measurement trends and equipment performance
• Justify disposition decisions using objective evidence and scientific rationale
• Lead remediation and improvement initiatives across Engineering, Manufacturing, Validation, Laboratory Operations, and Quality
• Manage project timelines, prioritize activities, and ensure deliverables are met
• Train personnel, influence stakeholders, and implement lasting improvements to metrology processes and procedures

Requirements

• Bachelor's degree in Engineering, Quality, Metrology, or a related technical discipline
• 5+ years of experience in metrology, calibration systems, or equipment quality engineering within a regulated industry (medical device, pharmaceutical, biotech, aerospace, or similar)
• Demonstrated experience leading calibration program remediation, including gap assessments, CAPA execution, and audit response
• Strong technical expertise in dimensional metrology, measurement system analysis (MSA), and calibration principles
• Advanced understanding of: Measurement uncertainty, Tolerance analysis, Traceability, Guard banding, Calibration intervals, Fitness-for-use decision rules (PAR, TMU, Z%, RSS)
• Hands-on experience with a wide range of manufacturing and inspection equipment, including: Ultrasonic welders, pneumatic presses, vision systems, automated assembly cells, injection molding equipment, packaging equipment (FFS, band sealers, shuttle sealers), CMMs, force/torque systems, leak and flow instruments, environmental monitoring equipment
• Strong knowledge of quality system regulations and standards, including: ISO 13485, 21 CFR Part 820 / QMSR, ISO 17025 principles, 21 CFR Part 11 (as applicable), Gage R&R and MSA methodologies
• Proven ability to author and revise calibration procedures, deviations, CAPAs, impact assessments, and risk assessments
• Experience supporting internal, customer, and regulatory audits
• Strong analytical and statistical skills; proficiency with Minitab or equivalent tools
• Demonstrated ability to perform OOT/OOC impact assessments and data-driven decision making
• Strong project management skills with the ability to lead remediation efforts, prioritize tasks, and meet aggressive timelines

Preferred Qualifications

• Experience working in medical device metrology programs
• Familiarity with cleanroom environments and standards: ISO 9001, ISO 13485, ISO 17025, ISO 10012, ANSI/NCSL Z540
• Working knowledge of: ProCal V5, Siemens Teamcenter