Senior Quality Engineer - Metrology

HonorVet Technologies; Houston (TX); On-site; USD 110,000 - 140,000; Full time

Job summary

HonorVet Technologies in Houston seeks a Senior Quality Engineer with 5+ years of metrology and calibration experience to lead remediation across regulated environments.

You will assess current programs, drive CAPAs, and coordinate audits, with strong emphasis on measurement uncertainty, MSA, and traceability. Collaboration across Engineering, Manufacturing, Validation, and QA is essential.

This 12-month engagement offers challenging projects and visibility into critical compliance initiatives.

Qualifications

• 5+ years of metrology and calibration systems experience in regulated manufacturing.
• Ability to lead remediation and audit readiness.
• Strong background in measurement uncertainty, tolerance analysis, traceability.
• Experience with calibration procedures and CAPAs.

Responsibilities

• Lead remediation of metrology/calibration programs in regulated environments.
• Address audit observations and regulatory findings related to metrology.
• Improve calibration compliance and governance; reduce overdue calibrations.
• Perform gap assessments and develop remediation plans.
• Evaluate impact of out-of-tolerance conditions on product quality and validation.

Skills

Metrology

Calibration

MSA / Gage R&R

Statistical analysis

Cross-functional leadership

Project management

Tools

Minitab

Job description

HonorVet Technologies (SDVOSB) provides specialized and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research laboratories, and life sciences organizations across the United States. With strong delivery capabilities and rapid turnaround times, we support contract, direct hire, project-based, and consulting staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing, validation, and scientific operations. Our dedicated recruitment team focuses on delivering qualified life sciences and pharmaceutical professionals efficiently while ensuring quality, compliance, and client satisfaction.

Job Title: Senior Quality Engineer - Metrology
Job Location: Houston, TX
Job Duration: 12 Months

Ideal Candidate Summary

• A successful candidate would be a Senior Quality Engineer with 5+ years of experience in metrology and calibration systems, capable of assessing the current state of the program, identifying compliance and technical gaps, performing risk-based impact assessments, and leading a comprehensive remediation effort that can withstand internal audits, customer audits, and regulatory inspections.

Primary Responsibilities

Calibration Program Remediation Expertise

• Requirement: Minimum 2 years of experience leading or supporting remediation of metrology/calibration programs in a regulated manufacturing environment (medical device, pharmaceutical, aerospace, or similar).
• Expected Evidence:
  • Experience addressing audit observations, CAPAs, or regulatory findings related to metrology systems.
  • Proven success improving calibration compliance, reducing overdue calibrations, and strengthening calibration governance.
  • Ability to perform gap assessments and develop sustainable remediation plans.

Advanced Metrology Technical Knowledge

• Requirement: Demonstrated expertise in dimensional metrology, measurement system analysis, and calibration principles.
• Expected Evidence:
  • Strong understanding of measurement uncertainty, tolerance analysis, traceability, guard banding, and calibration intervals.
  • In-depth knowledge of fitness-for-use evaluations and decision rules, including PAR, TMU, Z%, and RSS guardbanding methodologies
• Experience with Ultrasonic Welders, Pneumatics Presses, Vision Systems, Automated Assembly Cells, Injection Molding Equipment, Packaging Equipment (Form-Fill-Seal Machines, Band Sealers, Shuttle Sealers), CMMs, force/torque measurement, environmental monitoring equipment, leak and flow instruments.
• Ability to evaluate the impact of out-of-tolerance conditions on product quality and validation activities.

Quality Systems and Regulatory Compliance

• Requirement: Strong working knowledge of quality system requirements governing calibration and inspection equipment.
• Expected Evidence:
  • Expertise in 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
  • Experience authoring and revising calibration procedures, impact assessments, deviations, CAPAs, and risk assessments.
  • Ability to successfully support internal, customer, and regulatory audits.

Data-Driven Risk Assessment and Decision Making

• Requirement: Ability to independently assess calibration events and determine product impact using risk-based methodologies.
• Expected Evidence:
  • Experience conducting OOT/OOC impact assessments.
  • Ability to analyze historical calibration data, measurement trends, and equipment performance.
  • Strong statistical background, including Minitab or equivalent analytical tools.
  • Demonstrated capability to justify disposition decisions using objective evidence and scientific rationale.

Cross-Functional Leadership and Change Management

• Requirement: Proven ability to lead cross-functional initiatives and drive sustainable process improvements.
• Expected Evidence:
  • Experience partnering with Engineering, Manufacturing, Validation, Laboratory Operations, and Quality teams.
  • Strong project management skills with the ability to prioritize remediation activities and meet aggressive timelines.
  • Demonstrated success training personnel, influencing stakeholders, and implementing lasting improvements to metrology processes and procedures.

Preferred Qualifications

• Familiarity with cleanroom environments and standards such as ISO 9001, ISO 13485, ISO 17025, ISO 10012, and ANSI/NCSL Z540.
• Working knowledge of ProCal V5
• Working knowledge of Siemens Teamcenter
• Metrology Experience in the medical device industry