Staff Quality Engineer, CAPA

Key Responsibilities

• Acting as the CAPA technical investigation specialist you will lead and mentor teams performing root cause analysis using appropriate techniques to conceive solutions and implementation of changes, and devise effectiveness monitoring strategies
• Monitoring CAPA activities for investigations and action item implementation
• Perform eCAPA software administration for EtQ and TrackWise
• Reporting of CAPA program status, including trending CAPA metrics for actions and solutions and documenting all phases of CAPA activity in compliance with applicable standards, and procedural requirements
• Staff QE maintains CAPA records in a state of audit readiness
• Guiding cross-functional teams assigned to product CAPAs to ensure verification and/or validation of corrective and preventive actions are effective and do not adversely affect the finished product
• Work with all levels of management to ensure CAPA action plans are supported and that costs/resources needed to implement the plan are available
• Provide training, awareness and promote enthusiasm in the business for CAPA process

Minimum Requirements

• A Bachelor’s Degree or higher, Engineering or Science field preferred with strong technical capability
• 5 or more years’ QA experience in medical device industry, with a solid understanding of the CAPA process and its potential to drive product quality improvement

Ideal Characteristics

• The Staff Quality Engineer should have a proven record of developing new skills quickly and cross-pollinate the takeaways from one area to another
• Ability and willingness to dig deeper, take the ownership of the issue on hand and make a meaningful contribution towards investigation and resolution
• Excellent organization skills to manage many simultaneous projects
• Attention to detail – Client's Staff Quality Engineers must show precision in work, especially as it relates to understanding and documenting complex quality issues
• Excellent writing skills and able to summarize issues in a clear, succinct, and accurate manner that effectively conveys issues to the reader
• Effective interpersonal skills – Work with peers throughout the organization and be effective in engaging resources
• Excellent critical analytical skills – Ability to find root cause of why an issue occurred. Ability to review action plans and determine if the actions taken effectively address the issue