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