Quality Systems Engineer

4 days ago


Pittsburgh, Pennsylvania, United States Integrated Resources Full time
About the Role

We are seeking a highly skilled Quality Systems Engineer to join our team at Integrated Resources. As a key member of our quality assurance department, you will be responsible for ensuring the highest level of quality in our products and processes.

Key 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
  • Perform 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 Producting 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:

  • 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 year's 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 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
  • Strong reasoning and logical thinking skills
  • Excellent written and verbal communication skills in English

Estimated Salary: $120,000 - $150,000 per year, depending on experience



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