The Role
Leads remediation and improvement of metrology and calibration programs in regulated manufacturing environments. Conducts gap assessments, CAPAs, audit responses, risk-based impact assessments, out-of-tolerance evaluations, and calibration governance improvements. Applies dimensional metrology, measurement uncertainty, tolerance analysis, traceability, guard banding, and statistical analysis using Minitab. Authors quality documentation, supports audits, evaluates manufacturing and inspection equipment, manages remediation timelines, trains personnel, and coordinates improvements across engineering, manufacturing, validation, laboratory, and quality teams.
Summary Generated by Built In
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.
Requirements
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
Benefits
- Shift: Administrative
- Contract Duration: 12 months
- Location: Onsite
Skills Required
- 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.
- Experience leading calibration program remediation, including gap assessments, CAPA execution, and audit response.
- Strong technical expertise in dimensional metrology, measurement system analysis, and calibration principles.
- Advanced understanding of measurement uncertainty, tolerance analysis, traceability, guard banding, calibration intervals, and fitness-for-use decision rules.
- Hands-on experience with ultrasonic welders, pneumatic presses, vision systems, automated assembly cells, injection molding equipment, packaging equipment, CMMs, force/torque systems, leak and flow instruments, and environmental monitoring equipment.
- Strong knowledge of ISO 13485, 21 CFR Part 820/QMSR, ISO 17025 principles, 21 CFR Part 11, Gage R&R, and MSA methodologies.
- 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 with proficiency in Minitab or equivalent tools.
- Experience performing OOT/OOC impact assessments and data-driven decision-making.
- Strong project management skills, including leading remediation efforts, prioritizing tasks, and meeting aggressive timelines.
- Experience working in medical device metrology programs.
- Familiarity with cleanroom environments and ISO 9001, ISO 13485, ISO 17025, ISO 10012, and ANSI/NCSL Z540 standards.
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The Company
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
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