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.
RequirementsQualifications- 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
Benefits- Shift: Administrative
- Contract Duration: 12 months
- Location: Onsite
