We are seeking an experienced Quality Process Validation Engineer for a short-term contract position ending in March. This role focuses on quality system support, process improvement, and software validation to enhance compliance and operational efficiency.
Responsibilities
- Provide quality system support by developing and updating supplier and service quality contracts and quality plans.
- Write and implement Corrective and Preventive Actions (CAPAs) to address process and procedural gaps, ensuring compliance with regulatory standards.
- Upgrade and 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, to ensure accuracy and reliability.
- Collaborate with cross-functional teams to identify and resolve quality issues, driving continuous improvement initiatives.
- Document and maintain accurate records of validation activities and quality system updates in compliance with organizational standards.
- Support audits and inspections by ensuring all quality and validation activities meet applicable regulatory requirements.
Qualifications
- 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.
- Familiarity with regulatory standards and quality system requirements in the medical device industry.
- Excellent problem-solving and organizational skills, with attention to detail.
Location
Employment Type
About Ventura Solutions
Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.
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