Senior Quality Engineer (Production)

Location: Office-based in Bellaterra for 2026 and Barcelona at PCB from 2027

Company

hirify.global develops graphene-based neuroelectronic interfaces and neural solutions designed to help cure brain disorders.

What you will do

• Own and continuously improve production quality controls across manufacturing and microfabrication processes.
• Oversee production controls, cleanroom conditions, environmental monitoring, traceability, in-process controls, and final quality controls.
• Lead quality oversight for production and laboratory equipment, including qualification, calibration, maintenance, requalification, and equipment-related deviations.
• Lead process and test method validation activities, including validation strategy, acceptance criteria, protocols, deviations, and reports.
• Lead nonconformity and quality investigations, root-cause analysis, CAPA, effectiveness verification, and systemic quality improvements.
• Coordinate quality workstreams with Manufacturing, Microfabrication, Development, Supply Chain, QARA, suppliers, and contract manufacturing organizations.

Requirements

• Bachelor’s degree in Biomedical Engineering, Industrial Engineering, Materials Science, Micro/Nanotechnology, Life Sciences, or a related technical field.
• 5+ years of quality engineering experience in a regulated manufacturing environment, preferably medical devices.
• Strong experience with process validation, equipment qualification, manufacturing process controls, nonconformity investigations, root-cause analysis, and CAPA.
• Working knowledge of ISO 13485 requirements covering production, infrastructure, work environment, monitoring and measurement equipment, process validation, traceability, nonconforming products, and CAPA.
• Experience with production controls, inspection or batch records, DMR/DHR documentation, equipment calibration, and manufacturing quality evidence.
• Fluent professional English is required for controlled documents, reports, deviations, and quality records.

Nice to have

• Experience with cleanroom or controlled-environment manufacturing, ISO-classified areas, particle monitoring, environmental monitoring, and contamination control.
• Experience with microfabrication, semiconductor, thin-film, electrochemical, microassembly, implantable-device, or active-medical-device processes.
• Knowledge of EU MDR 2017/745, FDA 21 CFR 820/QMSR, ISO 14971, validation master plans, and test method validation.
• Experience with eQMS, MES, ERP, or PLM environments, as well as supplier or CMO quality oversight.

Culture & Benefits

• Collaborative environment focused on open communication, knowledge sharing, mutual respect, and diverse perspectives.
• Opportunity to contribute to healthcare technology with meaningful societal impact.
• Exposure to advanced technologies, tools, and innovative neural solutions.
• Flexible compensation scheme and private health insurance.
• Training bonus, access to Udemy, 23 vacation days per year, and Christmas week off.
• Despite flexible working modalities, this role is office-based because of its production responsibilities.

Hiring process

• Applications must be submitted in English.