Senior Quality Assurance Specialist

7 days ago


Pittsburgh, Pennsylvania, United States APN Software Services Inc Full time
About the Role

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at APN Software Services Inc. This is a full-time position based in Bakery Square, with the opportunity to work from home and potentially relocate to Murrysville, PA in the future.

Job Summary

This role will involve working as a subject matter expert on Corrective and Preventive Actions (CAPAs) within our organization. You will be responsible for reviewing and facilitating CAPA investigations, ensuring timely implementation of solutions, and monitoring their effectiveness.

Responsibilities
  • Critically review product and process CAPAs in various stages of the CAPA workflow
  • Facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring
  • Support updating 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, including gaining cross-functional resources' commitment, 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 in implementing 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
Requirements
  • Bachelor's degree in an engineering or scientific-related field or equivalent technical experience working in a medical device environment
  • At least 10 years of 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
Benefits and Compensation

We offer a competitive salary of $120,000 - $150,000 per annum, commensurate with experience, plus a comprehensive benefits package including health insurance, retirement plan, and paid time off. Our company culture values continuous learning, teamwork, and innovation, providing opportunities for professional growth and development.



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