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Position Summary

Vanguard Solutions is seeking an experienced Quality Engineer to support a medical device manufacturing organization with a primary focus on Test Method Validation (TMV).

This is a six (6) month minimum contract. The consultant will assess existing manufacturing inspection and test methods that have not previously been validated, evaluate those methods against current Quality System procedures and Test Method Validation requirements, identify compliance or technical gaps, and develop an appropriate validation strategy.

The engineer will then be responsible for authoring, executing, analyzing, and documenting attribute and variable Test Method Validations, including Measurement System Analysis (MSA), Gage R&R, and Attribute Agreement studies as applicable.

The role may also support CAPA and Nonconformance (NCR) activities as needed.

This is a hands-on individual-contributor position requiring close collaboration with Quality, Manufacturing Engineering, inspectors/operators, and other cross-functional stakeholders.

Primary Responsibilities

• Review existing manufacturing test and inspection methods that have not been formally validated.
• Assess each test method against current internal SOPs, procedures, acceptance criteria, and Quality System requirements.
• Perform a documented gap assessment to determine whether the existing method is adequately defined and suitable for validation.
• Review test-method instructions for clarity, objectivity, repeatability, equipment requirements, operator technique, sample preparation, and acceptance criteria.
• Determine whether methods require attribute or variable Test Method Validation.
• Develop an appropriate TMV strategy based on the type of measurement, method risk, intended use, and applicable procedural requirements.
• Author TMV protocols, including study design, sample selection, appraisers/operators, repetitions, acceptance criteria, statistical methods, and predefined requirements.
• Execute or coordinate execution of TMV studies with operators, inspectors, Quality, and Manufacturing Engineering.
• Perform variable Measurement System Analysis / Gage R&R studies.
• Perform attribute Test Method Validation / Attribute Agreement Analysis.
• Evaluate repeatability, reproducibility, operator/appraiser variation, equipment variation, and method variation.
• Evaluate attribute-method performance including false acceptance, false rejection, within-appraiser agreement, and between-appraiser agreement, as applicable.
• Analyze TMV results using appropriate statistical techniques and software such as Minitab.
• Investigate unacceptable or marginal TMV results and determine whether deficiencies originate from the method, equipment/fixture, operator technique, sample selection, acceptance criteria, or inherent product variation.
• Recommend and implement improvements to inspection/test procedures when a method is not suitable for validation.
• Update or support updates to test methods, inspection procedures, work instructions, and related controlled documentation.
• Author final TMV reports documenting study execution, statistical analysis, deviations, conclusions, and validation status.
• Ensure TMV documentation complies with applicable internal procedures and medical-device Quality System requirements.
• Maintain traceability between the test method, applicable requirements/specifications, validation protocol, results, and final report.
• Support CAPA, NCR, and root-cause investigations as required.
• Participate in nonconformance investigations, product-impact assessments, containment activities, dispositions, and corrective actions when needed.
• Collaborate closely with Quality Engineering, Manufacturing Engineering, Operations, R&D, and inspection personnel.

Required Qualifications

• Bachelor’s degree in Engineering, Science, Quality, or a related technical discipline.
• Experience working in a medical-device or similarly regulated manufacturing environment.
• Demonstrated hands-on experience with Test Method Validation.
• Experience independently reviewing an existing test or inspection method and determining whether it is suitable for validation.
• Experience developing TMV protocols and reports, not solely reviewing or approving documentation prepared by others.
• Hands-on experience with variable Gage R&R / Measurement System Analysis.
• Hands-on experience with attribute Test Method Validation / Attribute Agreement Analysis.
• Working knowledge of repeatability and reproducibility concepts.
• Experience establishing appropriate sample sizes, operators/appraisers, repetitions, and acceptance criteria for TMV studies.
• Ability to interpret and troubleshoot failed or marginal TMV results.
• Experience using Minitab or equivalent statistical software.
• Strong technical-writing skills.
• Working knowledge of ISO 13485, FDA Quality System requirements, and risk-based Quality Engineering principles.
• Experience with root-cause analysis and structured problem-solving techniques.

Preferred Qualifications

• Experience validating inspection methods used in catheter, guidewire, balloon, delivery-system, or other minimally invasive medical-device manufacturing.
• Experience with dimensional inspection, visual inspection, tensile testing, leak/burst testing, bond-strength testing, or similar medical-device test methods.
• Experience with CMM, optical measurement systems, tensile testers, force gauges, microscopes, calipers, micrometers, or other inspection equipment.
• Experience with CAPA and NCR investigations.
• Experience with PFMEA/FMEA and ISO 14971 risk-management principles.
• Experience working directly with manufacturing operators and inspectors to improve inspection/test methods.

Key Deliverables

• Inventory/review of assigned unvalidated test methods
• Assessment of each method against the current TMV SOP/procedure
• Documented gap assessment and recommended remediation
• Updated test/inspection methods where required
• Attribute or variable TMV protocols
• Execution of TMV studies
• Statistical analysis of study results
• Investigation/remediation of failed or marginal methods
• Final TMV reports and validation conclusions
• Supporting CAPA/NCR documentation where applicable