# Sr. Quality Engineer-Metrology

> BioPharma Consulting JAD Group · Houston, United States · Contract · Posted 2026-07-10

**Workplace:** on_site

## Description

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

-   Working knowledge of:

-   **ProCal V5**
-   **Siemens Teamcenter**

## Benefits

-   **Shift:** Administrative
-   **Contract Duration:** 12 months
-   **Location:** Onsite

## Apply

[Apply at BioPharma Consulting JAD Group](https://apply.workable.com/biopharma-consulting-jad-group/j/4BB59E0852/apply)

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