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Quality Engineer

1 month ago

Cambridge, United States Insight Global Full time
Job DescriptionJob Description

Job Description:

Insight Global is seeking a SME in Corrective and Preventative Actions (CAPA) to analyze and advise involved teams throughout the various end-to-end CAPA investigation processes. The responsibilities of this person will be as follows:

  • Complete product and process CAPA review tasks such as identifying issue descriptions, reviewing data, facilitating root cause analysis, advising on solutions, implementing solutions, and effective monitoring of the product post-CAPA
  • Initiative CAPA investigations and advise on solutions to cross-functional teams
  • Manage CAPA activities across all cross-function teams, including scheduling CAPA team meetings, ensuring the deliverable timeline will be met, ensuring effective monitoring post analysis, represent the CAPAs during audits and Review Board meetings, and mentoring the team throughout the analysis process
  • Confidently work in a high pressure environment while delivering on multiple projects with urgency

Must Haves:

-Bachelors in Engineering or related field

- 5-7 years practical experience with CAPA - medical device industry preferred

  • Root cause analysis methodologies, statistical sampling for effectiveness

- Able to understand and analyze complex problems, including software and hardware design issues

- Investigating issues using technical root cause analysis

- 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

Company DescriptionDivision-D is an omnichannel digital media partner serving both agencies and brands. We provide a full-service approach for our clients executing strategic media campaigns across a variety of digital channels with highly advanced audience targeting, premium inventory partnerships, and impactful ad formats at scale.