Experience Inc. Jobs

Job Description

Insight Global is looking for a EUMDR Quality Consultant for a CPG clients to sit in Princeton 3 days a week. This candidate will support their Global Markets Group within Quality for new products, marketed products, and QMS to support the medical device portfolio in the EU and Africa. They will support document requests for new product registration, lead new product development plans, provide quality support for internal stakeholders including RA, marketing, sales, and manufacturing. They will investigate CAPAs, NCRs, and product escalations for all marketed products. And finally they will compile data and metrics of their Agile System (PLM & PQM) as well as EDMS for agreement remediation. They will serve as internal point of contact and collaborate with engineering, regulatory, clinical and operations, and manufacturing functions to ensure quality standards are met per EUMDR.

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

8-10 years within a quality environment

Thorough understanding of EUMDR

International support

NCR, CAPA, Investigations exp

Lead reviewing, and the approval of technical protocols and reports for new distribution internationally 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.