Quality & Compliance Validation Engineer

Position: Quality & Compliance Validation Engineer Location: Los Gatos, CA (Local candidates only)

Experience: 7+ years Duration: 12+ months contract

Overview:

We’re seeking an experienced Quality & Compliance Validation Engineer responsible for process validation and ensuring FDA/ISO compliance within a medical device manufacturing environment. The role focuses on maintaining audit readiness, driving process improvements, and executing validations that meet regulatory and quality standards.

Qualifications

• Bachelor’s or Master’s degree in Engineering

• 7+ years of experience in the medical device industry and product development

• Strong knowledge of FDA QSR and ISO 13485 quality systems

• Excellent documentation, communication, and problem-solving skills

• Detail-oriented, adaptable, and comfortable working in cleanroom environments

• Experience in startup or fast-paced manufacturing settings preferred

• Key Responsibilities:

• Stay current with FDA, ISO, and GHTF guidance requirements

• Develop and maintain validation documentation, including Master Plans, Protocols, Reports (IQ/OQ/PQ/PPQ), PFMEA, and Monitoring Plans

• Execute DOE and physical testing using equipment such as Instron, Mark-10, and Micro-Vu

• Perform process validation for manufacturing methods such as adhesive bonding, UV curing, pouch sealing, 3D printing, braiding, laminating, thermoforming, and laser cutting/welding

• Support supplier process validations (laser welding, injection molding, luer bonding, etc.)

• Conduct Attribute and Variable Test Method Validations

• Apply statistical tools for sampling, data analysis, and documentation

• Plan and manage projects using Gantt charts, task lists, and structured review meetings

• Lead problem-solving initiatives using A3 and Six Sigma DMAIC methodologies

• Provide support for related validation activities including Facility, Packaging, Sterilization, eQMS, and ERP/CRM systems