Senior Quality Engineer - Metrology

Aequor; Houston (TX); Vor Ort; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

Aequor is seeking a Senior Quality Engineer with 5+ years of experience in metrology and calibration systems to assess current state, identify gaps, and lead a remediation program that withstands internal and regulatory audits.

You will drive risk-based assessments, apply MSA principles, and coordinate cross-functional teams across Engineering, Manufacturing, Validation, Laboratory Operations, and Quality to deliver sustainable calibration governance and compliant processes.

Qualifikationen

• 5+ years in metrology/calibration programs in a regulated manufacturing environment.
• Experience addressing audit observations, CAPAs, or regulatory findings related to metrology systems.
• Strong knowledge of metrology concepts, calibration principles.
• Experience with calibration procedures, impact assessments, deviations, risk assessments.
• Ability to lead cross-functional remediation and audits.

Aufgaben

• Lead calibration program remediation in a regulated environment.
• Perform gap assessments and develop remediation plans.
• Assess calibration events using risk-based methods.
• Support internal, customer, and regulatory audits.
• Collaborate with Engineering, Manufacturing, Validation, Laboratory Operations, and Quality teams.

Kenntnisse

Measurement uncertainty

Tolerance analysis

Traceability

Guardbanding

MSA (Gage R&R)

Minitab statistics

Validation support

Tools

ProCal V5

Siemens Teamcenter

CMMs

Measurement equipment

Jobbeschreibung

Description: 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.

In This Role, the Primary Responsibilities Will Include:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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

Custom Fields:

• Name: System Access Required Value: Yes
• Name: Remote Worker Value: No
• Name: Worker Time Type Value: Full Time
• Name: Invoice Type Value: USA-ARL-Staffing-USD
• Name: Work Desk Phone Number Required Value: No
• Name: Badge ID Required Value: Yes
• Name: Supervisory Org Value: QA - HOU Quality Control(Victor Aguero)-10020016
• Name: Workspace Value: None