Quality Engineer

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 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 and 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.

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 2 years of experience in Manufacturing environments preferred.
• Strong communication and teamwork skills.

Job Type: Full-time

Benefits:

• Dental insurance
• Employee assistance program
• Employee discount
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• 8 hour shift

Work Location: In person