Working within a team environment of shared project goals:
• Conduct product and process Corrective and Preventive Action (CAPA) Investigations from Issue identification through Implementation of solution and effectiveness monitoring.
• Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and providing CAPA deliverables per project timelines.
Document all phases of CAPA activity in compliance with applicable standards including 21 CFR part 820.1 00 and ISO 13485, and procedural requirements.
• Maintain CAPA records, keeping them in a state of audit readiness.
• Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques.
• Analyze quality monitoring data sources and apply statistical techniques to
identify existing and potential causes of non-conformances.
• Guide cross functional teams assigned to product CAPA:. to ensure verification and/or validation of corrective and preventive actions are effective and do not adversely affect the finished product.
• Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
• Provide periodic CAPA trending data to management for review.
• Serve a.s TrackWise tool SuperUser/expert.
Specific skill requirements for this role include:
• Bachelor's degree with ? 5 years of related experience quality systems engineering; or a Master's degree with ? 3 years of related experience quality systems engineering.
• Bachelor's degree in an engineering or scientific related field.
• 5 to I0 years related experience in the medical device industry. Demonstrated ability to effectively interact with and influence employees, and managers on all levels.
Must be goal-oriented and proactive in problem solving, coupled with creativity and a high energy level.
• Strong understanding of FDA regulations, international regulations. Strong written and verbal communication skills.
• Strong project management skills.
• Must be able to function with minimal supervision.