Senior Quality Engineer

Barrington James; Cataluña; Presencial; EUR 55.000 - 75.000; Jornada completa

Descripción de la vacante

Barrington James is assisting a leading medical devices company in Barcelona to recruit a Senior Quality Engineer – Production. You will own and improve quality controls across manufacturing, drive CAPA actions, and oversee validation activities in a regulated environment.

The role requires 5+ years in quality engineering, strong process validation and equipment qualification expertise, and fluency in English. Expect a senior, hands-on position within a cutting-edge neurotechnology field.

Formación

• Bachelor’s degree in Engineering, Life Sciences, Materials Science, Micro/Nanotechnology, or a related technical discipline.
• 5+ years of Quality Engineering experience in a regulated manufacturing environment, ideally medical devices.
• Strong experience with process validation, equipment qualification, and manufacturing process controls.
• Solid understanding of ISO 13485 and quality requirements relating to production, validation, traceability, equipment, nonconformities, and CAPA.
• Proven experience leading investigations, root-cause analysis, corrective actions, and effectiveness checks.
• Professional fluency in English.

Responsabilidades

• Own and continuously improve quality controls across manufacturing and production processes.
• Identify systemic risks and drive corrective actions that improve process robustness, product quality, and manufacturing readiness.
• Provide quality oversight of controlled environments, production areas, equipment, and critical manufacturing processes.
• Lead or provide technical direction for process validation, test method validation, and equipment qualification activities.
• Review validation strategies, protocols, acceptance criteria, deviations, and reports to ensure scientifically sound and traceable evidence.
• Lead complex nonconformity investigations, root-cause analysis, CAPA, and effectiveness verification.
• Monitor production quality indicators such as yield, nonconformities, inspection results, equipment status, and CAPA performance.

Conocimientos

Quality engineering

Regulatory manufacturing

English fluency

Educación

Bachelor’s degree in Engineering or related field

Descripción del empleo

Senior Quality Engineer – Production | Medical Devices

Location: Barcelona

We are supporting a highly innovative medical technology company whose mission is to develop next-generation neurotechnology designed to address some of the most challenging neurological disorders.

Our client brings together science, engineering, medicine, and advanced materials technology to develop minimally invasive neural interfaces capable of interacting with the nervous system. Their work sits at the intersection of medtech, neurotechnology, microfabrication, and advanced manufacturing, with the potential to make a meaningful difference to patients worldwide.

Responsibilities:

• Own and continuously improve quality controls across manufacturing and production processes.
• Identify systemic risks and drive corrective actions that improve process robustness, product quality, and manufacturing readiness.
• Provide quality oversight of controlled environments, production areas, equipment, and critical manufacturing processes.
• Lead or provide technical direction for process validation, test method validation, and equipment qualification activities.
• Review validation strategies, protocols, acceptance criteria, deviations, and reports to ensure scientifically sound and traceable evidence.
• Lead complex nonconformity investigations, root-cause analysis, CAPA, and effectiveness verification.
• Monitor production quality indicators such as yield, nonconformities, inspection results, equipment status, and CAPA performance.
• Coach and mentor Quality Engineers and manufacturing colleagues on quality practices, investigations, documentation, and risk management.

What we are looking for:

• Bachelor’s degree in Engineering, Life Sciences, Materials Science, Micro/Nanotechnology, or a related technical discipline.
• 5+ years of Quality Engineering experience in a regulated manufacturing environment, ideally medical devices.
• Strong experience with process validation, equipment qualification, and manufacturing process controls.
• Solid understanding of ISO 13485 and quality requirements relating to production, validation, traceability, equipment, nonconformities, and CAPA.
• Proven experience leading investigations, root-cause analysis, corrective actions, and effectiveness checks.
• Professional fluency in English.