| Job 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 |
|---|