Sr. Quality Engineer-Metrology

About the Role

We are seeking a highly experienced Senior Quality Engineer with 5+ years of expertise in metrology and calibration systems within a regulated manufacturing environment. The ideal candidate will assess the current state of the calibration program, identify compliance and technical gaps, perform risk-based impact assessments, and lead a comprehensive remediation effort that withstands internal audits, customer audits, and regulatory inspections.

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

Schedule

Shift: Administrative

Contract Duration

12 months

Location

Onsite