Validation Engineer

Responsibilities :

• Provide Quality oversight for the Commercial stage, including Design Transfer.
• Create / revise / execute SOPs to support combination product quality governance in the commercial stage.
• Evaluate design changes and provide quality input to support continuous improvement initiatives.
• Stay abreast of evolving regulatory requirements and ensure commercial products comply with applicable standards.
• Maintain compliance with global Risk Management processes in accordance with ISO and other applicable standards.
• Work cross-functionally with Subject Matter Experts from R&D, Clinical, and Operations to ensure the risk process is applied comprehensively.
• Create and provide Quality training as needed for cross functional stake holders and CMOs.
• Develop key relationships and interface extensively with internal stakeholders and contract manufacturers to address and resolve complex technical related drug device combination product, process and quality issues.
• Ensure that changes to commercial products are conducted in accordance with FDA QSR / QMSR, ISO , and other applicable standards.
• Writes and / or implements changes to controlled documents (, SOPs, Specifications, WIs, etc.) as needed.
• Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals, Medical Devices, and Combination Products worldwide.
• Executes changes to quality processes to ensure conformance and continuous improvement.
• Work with management and department personnel to achieve goals and strategic initiatives.
• Supports due diligence and internal or external audits / inspections as needed.
• Participate in annual product reviews and perform periodic review and update of DHF and RMF.
• Support complaints investigations and filter information back to the design and development team and CMOs.

Requirements :

• Must have + years of relevant experience and a Bachelor's degree in a Science or Engineering related field; or + years of relevant experience with a Master's degree in a Science or Engineering related field.
• Medical device experience preferred.
• Demonstrates in-depth knowledge of Quality principles, concepts, industry practices, and standards.
• Previous experience with combination devices is preferred (, Autoinjectors, co-packaged kits, pre-filled syringes).
• Quality experience in both clinical and commercial products.
• Strong project management and process improvement skills.
• Demonstrates understanding of and international quality systems regulations / standards to adopt best in class systems / processes and drive continuous improvement initiatives.
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
• Knowledge of ISO Risk Management tools (, Hazard Analysis / or Failure Mode Effects Analysis (FMEA)) is preferred.
• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.
30+ days ago