Position Summary
This is a full-time contract assignment expected to begin as soon as possible and continue through December 31, 2026, for an anticipated duration of approximately five months with the possibility of extension. Vanguard Solutions is seeking a Quality Engineer to support a catheter-focused business unit within a regulated medical device manufacturing organization. The ideal candidate will have hands-on experience leading and participating in Corrective and Preventive Actions (CAPAs), Nonconformance Reports (NCRs), and Test Method Validation activities.
The candidate must be experienced in both the execution and technical review of attribute and variable Test Method Validations. Prior experience with catheter manufacturing, catheter-based delivery systems, or similar minimally invasive medical devices is highly desirable.
Key Responsibilities
- Lead and participate in CAPA investigations from initiation through implementation, effectiveness verification, and closure.
- Lead and support NCR investigations involving product, process, material, and documentation nonconformances.
- Perform thorough root-cause investigations using appropriate problem-solving and statistical tools.
- Develop and implement containment, correction, corrective action, and preventive action plans.
- Author, execute, and review attribute and variable Test Method Validation protocols and reports.
- Evaluate test methods for accuracy, precision, repeatability, reproducibility, discrimination, and suitability for intended use.
- Support Attribute Agreement Analysis, Gage R&R, measurement-system analysis, and other statistical evaluations.
- Review validation data, identify discrepancies, and ensure conclusions are supported by objective evidence.
- Assess existing inspection and test methods to determine whether validation or revalidation is required.
- Review nonconforming material and participate in Material Review Board activities.
- Analyze quality and manufacturing data to identify trends, recurring failures, and opportunities for improvement.
- Collaborate with Manufacturing, R&D, Quality, Supplier Quality, and Regulatory teams.
- Author and revise procedures, work instructions, protocols, reports, and other quality-system documentation.
- Support internal, customer, and regulatory audits.
- Ensure CAPAs, NCRs, and validation activities are completed accurately and within established timelines.
Required Qualifications
- Bachelor’s degree in Engineering, Science, or a related technical discipline.
- Hands-on experience in a regulated medical device manufacturing environment.
- Demonstrated experience leading and participating in CAPAs and NCR investigations.
- Demonstrated experience executing and reviewing attribute and variable Test Method Validations.
- Experience performing root-cause analysis and developing technically sound corrective actions.
- Experience with statistical analysis and measurement-system evaluation.
- Strong technical writing and documentation-review skills.
- Ability to independently manage multiple investigations and validation activities.
- Strong cross-functional communication and problem-solving skills.
Preferred Qualifications
- Experience supporting the manufacture, inspection, testing, or development of catheters or catheter-based medical devices.
- Familiarity with catheter manufacturing processes such as extrusion, bonding, tipping, forming, coating, assembly, leak testing, tensile testing, and dimensional inspection.
- Experience with Attribute Agreement Analysis, Gage R&R, Minitab, or similar statistical tools.
- Experience with risk-management tools such as FMEA.
- Experience supporting regulatory inspections or quality-system audits.
Pay: $60.00 - $70.00 per hour
Benefits:
Application Question(s):
- Vanguard Solutions is unable to provide employment visa sponsorship for this position. Will you now or in the future require employer sponsorship to work in the United States?
- Are you available to commit to a full-time contract assignment expected to continue through December 31, 2026?
- How many years of hands-on Quality Engineering experience do you have in a regulated medical-device manufacturing environment?
- How many years of hands-on experience do you have leading or participating in CAPA and NCR investigations in medical-device manufacturing?
- Have you personally executed and technically reviewed both attribute and variable Test Method Validations in a regulated medical-device environment?
- Do you have Quality Engineering experience supporting catheter manufacturing or catheter-based medical devices?
- How many years of experience do you have using Minitab or similar statistical software for TMV, CAPA, or NCR analysis?
Ability to Commute:
- Carlsbad, CA 92008 (Required)
Work Location: In person
