EQVAL Group, Inc. is a company that provides services to the manufacturing industry ( Medical Devices, Pharmaceuticals, Biotechnologies, others ).
We work with an extraordinary group of professionals ( employees and contractors ) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.
The Validation Engineer (EU MDR) will play a critical role in supporting the EU MDR program activities for the technical filing of medical devices.
This role will focus on supporting validation processes, assessing documentation, identifying gaps, and executing remediation plans to ensure compliance with EU MDR requirements.
Minimum Requirements: Bachelor Degree in an Engineering or Natural Sciences field Knowledge and experience in cGMP in a Pharmaceutical or Medical Devices manufacturing environment.
Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
Good technical writing skills in English and Spanish.
Project management skills required.
Fully bilingual (English and Spanish).
Key Responsibilities : Data Gathering : Participate in the discovery and compilation of required documentation for evaluation, ensuring completeness and compliance with EU MDR requirements.
Gap Assessments : Evaluate all manufacturing documentation, including product device master records (drawings, specifications, bills of materials, production routers/instructions, procedures, labeling), process flow charts, and inspection reports (incoming, in-process, final).
Remediation Plan : Support the remediation plan by performing tasks such as validation documentation generation and execution, including change control, validation plans, protocols, and closure reports.
Cross-functional Collaboration : Work closely with cross-functional teams to support EU MDR technical filing, gap identification, and implementation of corrective actions.
Benefits: Dental insurance Health insurance Life insurance Paid time off Professional development assistance Referral program Schedule: 8 hour shift Day shift Monday to Friday Work setting: In-person Powered by JazzHR