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Process Validation Engineer

Process Validation Engineer

inSync StaffingLos Gatos, CA, United States
1 day ago
Job type
  • Temporary
Job description

Pay Range : $60-$80 / hr, paid weekly

Duration : 6-month contract

Overview :

Responsible for process validation to ensure FDA / ISO compliance and audit readiness for medical device manufacturing.

Qualifications :

  • Bachelor's or Master's in Engineering.
  • 7+ years in medical device industry and product development.
  • Knowledge of FDA QSR and ISO 13485 quality systems.
  • Strong documentation, communication, and problem-solving skills.
  • Detail-oriented, adaptable, and comfortable in a cleanroom environment.
  • Experience in startup environments preferred.

Key Responsibilities :

  • Maintain up-to-date knowledge of FDA, ISO, GHTF guidance.
  • Own all process validation documentation : Master Plan, Reports, IQ / OQ / PQ / PPQ, PFMEA, Monitoring Plans.
  • Perform DOE and physical testing using equipment like Instron, Mark 10, Micro-Vu.
  • Validate manufacturing processes (adhesive bonding, UV cure, pouch sealing, 3D printing, braiding, laminating, thermoforming, laser cutting / welding, etc.).
  • Support supplier validation for processes like laser welding, injection molding, luer bonding.
  • Conduct Attribute and Variable Test Method Validation.
  • Apply statistical methods for sample size determination and documentation.
  • Manage projects with Gantt charts, task lists, and meetings.
  • Solve problems using A3 and Six Sigma DMAIC methods.
  • Support related validations : Facility, Packaging, Sterilization, eQMS, Netsuite / ERP / CRM.
  • Benefits (Employee Contribution)

  • Health Insurance
  • Health Savings Account
  • Dental Insurance
  • Vision Insurance
  • Flexible Spending Accounts
  • Life Insurance
  • Retirement Plan
  • All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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    Validation Engineer • Los Gatos, CA, United States

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