CAPA Quality Engineer

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

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com. The EEOC "Know Your Rights" Poster is available here.

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-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

- Medical device industry experience
Project Manager background, especially over CAPA activities

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.