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Urgent! Process Validation Engineer Job Opening In Los Gatos California – Now Hiring inSync Staffing

Process Validation Engineer



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.



 



Required Skill Profession

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    Unlock Your Process Validation Potential: Insight & Career Growth Guide


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