Quality Engineer (Eu Mdr)

Detalles de la oferta

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 Quality Engineer (EU MDR) will support the EU MDR program by reviewing and updating validation processes and manufacturing documentation, identifying gaps, and executing remediation plans to ensure compliance with EU MDR requirements.
Responsibilities: Support Engineering and Quality teams in new product introductions and daily manufacturing processes.
Complete remediation tasks to ensure manufacturing processes meet EU MDR compliance requirements.
Manage Quality Systems, including: Development, implementation, and evaluation of process non-conformities.
Evaluation of CAPAs and deviations.
Generate and execute validation documentation (change control, validation plans, protocols, closure reports) and update manufacturing documents through site change orders for the remediation plan.
Review all manufacturing and validation documentation related to product families for EU MDR and Design History File (DHF) remediation.
Provide data for gap assessment reports and identify action items for remediation.
Collaborate with internal teams, external vendors, and customers as needed.
Conduct PFMEA assessments for suppliers and manufacturing processes.
Review and develop quality documentation and validations, including: Support assessment and update of manufacturing documentation, such as: Product device master record (drawings, specifications, BOM, production router, procedures, labeling, etc.).
Process flow charts, inspections (incoming, in-process, final), validation plans, and process validations.
Development and execution of IQ, OQ, PQ protocols.
Project Focus: Support the European Union Medical Device Regulation (EU MDR) and Design History File (DHF) improvement program.
Ensure conformance with EU MDR for technical filing of TT products manufactured and included in the EU MDR and Design History File (DHF) improvement program.
Requirements: BS in Engineering or Science, preferably.
Strong technical documentation skills in both English and Spanish.
Experience with EU MDR compliance and documentation preferred.
At least 3 - 5 years of knowledge or experience in Medical Device or Pharmaceutical manufacturing environments preferred.
Strong communication and teamwork skills.
  Powered by JazzHR


Salario Nominal: A convenir

Fuente: Talent_Ppc

Requisitos

Qa Technician

Audit and maintenance of all Quality Systems to comply with the QSR (cGMP's) regulations. Perform inspections of product at different process stages that are...


Kelly Science, Engineering, Technology & Telecom - Añasco

Publicado a month ago

Quality Engineer/Specialist

For Quality services in the Manufacturing area. WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's Degree in Engineering or related field and at least fou...


Flexible & Integrated Technical Services, Llc - Añasco

Publicado 6 days ago

Supplier Quality Engineer

For Material Engineering services in the Manufacturing area. WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's Degree in Engineering and at least three (...


Flexible & Integrated Technical Services, Llc - Añasco

Publicado a day ago

Técnico(A) De Calidad

Nos encontramos en búsqueda de Técnico(a) de Calidad para compañía ubicada en el área de Bayamón. Requisitos: * Disponibilidad de turnos rotativos, sabados d...


Xpand Staffing, Llc. - Bayamón

Publicado a month ago

Built at: 2025-02-06T22:42:09.050Z