Business Quality Engineer

Insight Global is looking for a Quality Engineer 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 and other products in the LATAM market. 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 learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
Required Skills & Experience
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
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.