Job Description An employer is seeking a Quality Engineer for a contract opportunity in either the Madison, WI, Cincinnati, OH or Raritan, NJ locations. This quality engineer will take the lead in conducting data analysis and ensuring thorough CAPA failure investigations. This role involves monitoring CAPA and non-conformance process metrics, as well as serving as a coach and advocate for Quality System processes while actively seeking opportunities for continuous improvement. Additionally, the Quality Systems Engineer will collaborate across the Franchise to support the harmonization and integration of an optimized Quality System. Other responsibilities will include tracking and reporting action plans for failure investigations, support CAPA, NC, design review boards and monitoring quality management system metrics. They will provide audit support in Madison, WI on a quarterly basis and will be expected to assist with 3rd party investigations from the registrar, notified body, FDA and customer. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements BS degree in Engineering, Sciences, or Business Analysis Experience working in an FDA regulated environment (pharma or medical device) 3+ years of experience working in an Operations, Manufacturing, Quality and/or Engineering Demonstrated skills in root cause analysis and failure investigation Project Management skills within excel, Project or ETQ direct medical device audit experience customer facing background located directly in Madison, WI null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.