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
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Lead or support remediation of metrology and calibration programs in regulated industries (medical device, pharmaceutical, aerospace, etc.).
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Conduct gap assessments, identify compliance deficiencies, and develop sustainable remediation plans.
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Address audit observations, CAPAs, and regulatory findings related to calibration systems.
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Improve calibration compliance, reduce overdue calibrations, and strengthen calibration governance.
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Apply deep knowledge of dimensional metrology, measurement system analysis, and calibration principles.
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Demonstrate strong understanding of measurement uncertainty, tolerance analysis, traceability, guard banding, and calibration intervals.
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Perform fitness‑for‑use evaluations and apply decision rules (PAR, TMU, Z%, RSS guardbanding).
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Support calibration and troubleshooting of equipment such as:
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Ultrasonic welders
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Pneumatic presses
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Vision systems
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Automated assembly cells
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Injection molding equipment
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Packaging equipment (FFS, band sealers, shuttle sealers)
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CMMs
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Force/torque systems
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Leak and flow instruments
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Environmental monitoring equipment
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Evaluate out‑of‑tolerance (OOT) conditions and determine product/validation impact.
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Ensure compliance with applicable standards and regulations, including:
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ISO 13485
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21 CFR Part 820 / QMSR
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ISO 17025 principles
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21 CFR Part 11 (as applicable)
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Gage R&R and MSA methodologies
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Author and revise calibration procedures, deviations, CAPAs, impact assessments, and risk assessments.
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Support internal, customer, and regulatory audits.
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Independently assess calibration events using risk‑based methodologies.
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Conduct OOT/OOC impact assessments and analyze historical calibration data.
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Apply statistical tools (Minitab or equivalent) to evaluate measurement trends and equipment performance.
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Justify disposition decisions using objective evidence and scientific rationale.
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Lead remediation and improvement initiatives across Engineering, Manufacturing, Validation, Laboratory Operations, and Quality.
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Manage project timelines, prioritize activities, and ensure deliverables are met.
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Train personnel, influence stakeholders, and implement lasting improvements to metrology processes and procedures.
Requirements
Qualifications
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Bachelor’s degree in Engineering, Quality, Metrology, or a related technical discipline.
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5+ years of experience in metrology, calibration systems, or equipment quality engineering within a regulated industry (medical device, pharmaceutical, biotech, aerospace, or similar).
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Demonstrated experience leading calibration program remediation, including gap assessments, CAPA execution, and audit response.
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Strong technical expertise in dimensional metrology, measurement system analysis (MSA), and calibration principles.
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Advanced understanding of:
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Measurement uncertainty
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Tolerance analysis
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Traceability
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Guard banding
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Calibration intervals
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Fitness‑for‑use decision rules (PAR, TMU, Z%, RSS)
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Hands-on experience with a wide range of manufacturing and inspection equipment, including:
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Ultrasonic welders
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Pneumatic presses
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Vision systems
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Automated assembly cells
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Injection molding equipment
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Packaging equipment (FFS, band sealers, shuttle sealers)
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CMMs
-
Force/torque systems
-
Leak and flow instruments
-
Environmental monitoring equipment
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Strong knowledge of quality system regulations and standards, including:
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ISO 13485
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21 CFR Part 820 / QMSR
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ISO 17025 principles
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21 CFR Part 11 (as applicable)
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Gage R&R and MSA methodologies
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Proven ability to author and revise calibration procedures, deviations, CAPAs, impact assessments, and risk assessments.
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Experience supporting internal, customer, and regulatory audits.
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Strong analytical and statistical skills; proficiency with Minitab or equivalent tools.
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Demonstrated ability to perform OOT/OOC impact assessments and data‑driven decision making.
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Strong project management skills with the ability to lead remediation efforts, prioritize tasks, and meet aggressive timelines.
Preferred Qualifications
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Experience working in medical device metrology programs.
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Familiarity with cleanroom environments and standards:
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ISO 9001
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ISO 13485
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ISO 17025
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ISO 10012
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ANSI/NCSL Z540
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Working knowledge of:
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ProCal V5
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Siemens Teamcenter
Benefits
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Shift: Administrative
- Contract Duration: 12 months
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Location: Onsite
