• 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.

Responsibilities:

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.