Bachelor's degree in engineering with 7+ years of experience in medical devices, or a master's degree with 5+ years of related experience.
In-depth knowledge of global regulations such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and ISO 14971.
Proven capability in root cause analysis and implementing corrective actions.
Strong project management skills, including managing cross-functional teams and CAPA timelines.
Experience analyzing complex problems in both software and hardware designs.
Responsibilities
Facilitate end-to-end CAPA investigations from issue identification to solution implementation.
Project manage CAPA activities by coordinating resources and scheduling team meetings.
Represent CAPAs during audits and lead discussions at CAPA Review Board meetings.
Mentor teams in root cause analysis techniques to enhance problem-solving capabilities.
Analyze quality data using statistical methods to pinpoint non-conformance causes.
Collaborate with management to ensure CAPA action plans are supported with necessary resources.
Independently generate and complete CAPA documentation and assessments.
Benefits
Opportunity to work on impactful CAPA engineering projects in a medical device setting.
Mentorship and leadership opportunities within cross-functional teams.
Engagement with high-level audits and regulatory processes, enhancing professional visibility.
Possibility to leverage statistical techniques for problem-solving in a regulated industry.
Professional development through exposure to complex quality and engineering challenges.
Full Job Description
Position Details:
These critical resources are being added to support the injunction lift and getting the CAPA program back to a healthy state.
Responsible for leading CAPA engineering activities like assessing complex investigations and corrective actions and reviewing test and other complex performance data, leading complex root cause analysis and complex quality problem solving.
Bachelor's engineering degree with 7+ years of related experience (strong Med Device), or a master's degree with 5+ years of related experience.
Job Responsibilities:
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.
Independently produces and completes CAPA (Corrective and Preventive Action) records.
Responsible for performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis, and quality problem-solving.
Notes:
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.
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.
