Validation and Compliance Specialist

3 days ago


San Jose, California, United States Ventura Solutions Inc. Full time
Job Overview

This Quality Process Validation Engineer role involves providing quality system support, process improvement, and software validation to enhance compliance and operational efficiency.

  • The ideal candidate will have proven experience in quality engineering, strong knowledge of CAPA processes, and hands-on experience with software validation.
  • They will be responsible for collaborating with cross-functional teams, identifying and resolving quality issues, and driving continuous improvement initiatives.
  • Additionally, they will document and maintain accurate records of validation activities and quality system updates, and support audits and inspections.
Key Responsibilities
  • Develop and update supplier and service quality contracts and quality plans.
  • Implement Corrective and Preventive Actions (CAPAs) to address process and procedural gaps.
  • Refine Standard Operating Procedures (SOPs), processes, and procedures to align with quality and regulatory requirements.
  • Perform software validation activities for test systems, including Excel macros and Python scripts.
Requirements
  • Bachelor's degree in Engineering.
  • Proven experience in quality engineering with a focus on quality systems and process validation.
  • Strong knowledge of CAPA processes and quality plan development.
  • Hands-on experience with software validation, including Excel macros, Python scripts, and test system integration.

Estimated Salary: $100,000 - $130,000 per year.

About Us

Ventura Solutions Inc. is a leading provider of medical device and combination product consulting, staffing, and training services. We pride ourselves on our deep industry expertise and outstanding talent pool.



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