Validation and Compliance Specialist
3 days ago
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.
- 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.
- 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 UsVentura 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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