Quality Engineer

Responsibilities:

• Critically review product and process Corrective and Preventive Actions (CAPAs) in various stages of the CAPA workflow.

• Facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring.

• Support updating the business processes relating to CAPA.

• 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.

• 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.

• Support and prepare spokespersons in representing 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.

• Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.

Requirements:

• At least a bachelor's degree in an engineering or scientific-related field or other plus equivalent technical experience working in a medical device environment.

• At least 10 years practical experience with CAPA.

• 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 14971Demonstrated 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.

• Strong reasoning and logical thinking skills.

• Excellent written and verbal communication skills in English.