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 be capable of assessing the current state of the calibration program, identifying compliance and technical gaps, performing risk‑based impact assessments, and leading a comprehensive remediation effort that withstands internal audits, customer audits, and regulatory inspections.
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.
Qualifications
• 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