Location: Bothell, WA
Duration: Until the end of year
Responsible for driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings.
• Facilitate 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 ensuring CAPA deliverables per project timelines
• Represent CAPAs during audits and CAPA Review Board meetings
• Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).
• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
• 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.
To succeed in this role, you should have the following skills and experience
• Engineering Degree or equivalent experience in medical device industry
• DfSS/DMAIC Black Belt (or equal by experience)
• 5+ years’ experience desired in a medical device or other regulated industry
• Able to understand and analyze complex problems, including software and hardware design issues.
• Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.
• Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
• Ability to audit the record for not only compliance to procedure, FDA, etc., but audit to assure statements are factual (i.e. follow the thread to assure evidence justifies the statement made in the record).
• Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.
• Strong Project Management skills, including ability to project manage all CAPA activities.
• Ability to analyze data and apply statistical techniques.
• Excellent written and verbal communication skills.