QA

Work Mode: Hybrid, location can be Murrysville or Cambridge

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.
• 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 produce and complete CAPA records.
• Perform timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis, and quality problem-solving.
• Lead CAPA engineering activities like assessing complex investigations and corrective actions, and reviewing test and other complex performance data.

Requirements:

• Bachelor’s engineering degree with over 5 years of related experience, or a Master’s degree with over 3 years of related experience.
• Understanding and analyzing 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.
• Strong Project Management skills, including the ability to project manage all CAPA activities.
• Ability to analyze data and apply statistical techniques.
• Excellent written and verbal communication skills.