About the role
Your Mission
We are scientists, doctors, techies and humanity lovers, with the mission of building neuroelectronic interfaces to cure brain disorders. INBRAIN harnesses the extraordinary material properties of Graphene, the world’s thinnest and nobel-prize winning material, to build safe, uninvasive and highly efficient neural solutions. Our mission is to decode and modulate neural networks to improve people's lives As a Senior Quality Engineer (Production), you will provide technical quality leadership across INBRAIN’s production, microfabrication and final quality control activities, ensuring that manufacturing processes are controlled, compliant, robust and capable of consistently delivering safe and high-quality medical devices. The role owns complex production quality workstreams and acts as a key technical partner to stakeholders in business areas like manufacturing or microfabrication, and external manufacturing partners.
The role is responsible for identifying and resolving systemic quality issues, leading complex quality initiatives and investigations, strengthening manufacturing and quality system controls, providing independent quality oversight of validation and equipment lifecycle activities, and driving continuous improvement across the product lifecycle. Operating with a high degree of autonomy, it influences cross-functional decisions across Manufacturing, Operations, Development, and Regulatory Affairs, provides technical guidance to colleagues, and escalates strategic quality risks to QARA leadership when appropriate.This position will be mainly office-based (Bellaterra based for 2026, Barcelona at PCB from 2027).
What You'll Do
Production Quality Controls & Manufacturing Readiness
- Lead and continuously improve quality controls across assigned manufacturing and microfabrication processes, ensuring alignment with approved procedures, work instructions, specifications, control plans, PFMEAs, risk controls and QMS requirements. Identify systemic risks and drive actions to improve process robustness, product quality and manufacturing readiness. - Drive the implementation and maintenance of production controls, including line clearance, contamination control, environmental conditions, identification and traceability, prevention of product mix-up, in-process controls and final inspection activities. - Own the design and process transfer, scale-up and manufacturing readiness activities, ensuring that production specifications, inspection methods, validation evidence, risk controls, training requirements and manufacturing documentation are adequately established before routine production. - Lead Quality Engineering oversight of manufacturing and inspection records, with a focus on traceability, data integrity, documentation robustness and DHR readiness. Identify recurring documentation issues or systemic weaknesses and drive improvements to manufacturing records, inspection records and production documentation processes. - Define Quality review of production changes, assessing potential impacts to validated state, product conformity, risk controls, traceability, regulatory commitments and manufacturing readiness. - Partner closely with Manufacturing, Microfabrication, Device Development and Supply Chain to ensure production processes remain controlled and capable throughout the product lifecycle.
Validation, Equipment & Measurement Systems
- Lead independent Quality oversight of process, equipment and test method validation activities within assigned manufacturing areas. - Define and govern validation strategies, risk-based acceptance criteria, protocols, deviations and reports, ensuring that validation evidence is scientifically and statistically justified, traceable to applicable requirements and sufficient to demonstrate process capability and control. - Drive Quality oversight of critical production and laboratory equipment, including qualification activities, calibration and maintenance compliance, requalification decisions and assessment of the impact of equipment changes or failures on product quality and process control. - Ensure production inspection and measurement methods are suitable for their intended use, including verification, validation and measurement system assessments where applicable. - Own the maintenance of validated processes and qualified equipment through periodic review, change assessment and risk-based decision making.
Nonconformity, CAPA & Change Control
- Lead complex nonconformity investigations related to production, equipment, facilities, cleanroom activities and manufacturing processes. - Apply structured root-cause analysis methodologies, challenge unsupported conclusions and ensure corrective and preventive actions are evidence-based and proportionate to risk. - Establish the effectiveness of implemented corrective actions and identify recurring or systemic issues requiring broader process improvements. - Drive manufacturing change control activities and assess the quality impact of proposed process, equipment, material, supplier, facility and inspection method changes. - Escalate significant quality issues, trends or validation gaps that may affect product safety, compliance, release readiness, manufacturing continuity or approved risk controls.
Cleanroom & Contamination Control Oversight
- Own Quality Engineering oversight of controlled environments and cleanroom activities within assigned manufacturing areas. - Lead implementation and maintenance of contamination-control measures, including personnel practices, gowning, cleanliness controls, material and equipment entry controls, environmental monitoring and response to environmental excursions. - Review environmental monitoring data, identify adverse trends and ensure appropriate investigations, risk assessments and corrective actions are performed when limits are exceeded. - Drive compliant behaviours and contamination-control awareness through coaching, training support and continuous improvement initiatives. - Support qualification and ongoing monitoring of facilities and controlled environments as required.
Supplier & CMO Production Quality
- Lead Quality Engineering oversight of production-related suppliers and contract manufacturing organizations (CMOs) whose activities may affect product quality, manufacturing robustness or supply continuity. - Define supplier qualification, audit follow-up, quality performance monitoring, investigation activities, supplier change assessments and implementation of risk control plans. - Analyze and drive supplier-related deviations, nonconformities and corrective actions, ensuring appropriate risk-based resolution when supplier performance impacts product quality. - Drive alignment with Supply Chain and Supplier Quality functions to ensure supplier controls remain effective and aligned with applicable regulatory and quality requirements. - Own external manufacturing transfers, manufacturing readiness assessments and quality oversight of outsourced production activities.
Quality Metrics, Continuous Improvement & Technical Leadership
- Lead the production quality performance metrics, including nonconformities, process trends, inspection results, environmental monitoring, validation status, equipment compliance and CAPA effectiveness. - Translate quality data into actionable recommendations that improve process capability, quality performance, manufacturing readiness and operational effectiveness. - Drive technical coaching and mentorship to Quality Engineers and production personnel on production quality, risk management, investigations, controlled manufacturing practices, documentation and quality systems. - Lead or support cross-functional quality improvement initiatives aimed at reducing risk, strengthening controls and improving quality culture. - Establish and maintain internal audits, external audits, notified body inspections and FDA readiness activities related to manufacturing operations, facilities, equipment, process controls and monitoring activities. - Act as the primary Quality Engineering partner for assigned manufacturing areas, providing independent quality judgement while working collaboratively with operational stakeholders.
What You'll Bring
- Bachelor's degree in biomedical engineering, Industrial Engineering, Materials Science, Micro/Nanotechnology, Life Sciences or a related technical field. - Over +7 years of experience in quality engineering within a regulated manufacturing environment, preferably medical devices, with demonstrated ownership of complex production quality activities. - Strong experience with process validation, equipment qualification and manufacturing process controls. - Working knowledge of ISO 13485 requirements for production, infrastructure, work environment, monitoring and measurement equipment, process validation, traceability, nonconforming product and CAPA (Must). - Demonstrated experience leading nonconformity investigations, root-cause analysis, CAPA and effectiveness verification. - Demonstrated ability to drive quality improvements and implement sustainable corrective actions across manufacturing processes. - Experience with production controls, inspection records, batch records, DMR/DHR documentation or equivalent manufacturing quality evidence. - Experience with sterile medical devices, microbiological controls and biohazard. - Experience supporting equipment calibration, maintenance, qualification, verification or validation activities. - Experience working cross-functionally with Manufacturing, Development, Supply Chain and external suppliers or CMOs. - Ability to review technical documentation, acceptance criteria, test records, deviations and quality reports with strong attention to detail.
Recruitment Process
- People & Culture Screening (30 min) – A brief introduction to learn about your background, career aspirations and interest in INBRAIN. - Hiring Manager Interview (60 min) – A deeper discussion focused on your experience, technical expertise, and alignment with the role and team. - Technical Interview (60 min) – As part of the recruitment process, candidates will be asked to complete a short take-home technical case and present their approach during a technical interview with members of the Microfabrication and Quality team. - Culture Fit Interview (45 min) - Conversations with key stakeholder and People & Culture Representative.
Why us?
We are looking for someone who Is ready to proactively bring new ideas to the team, push boundaries, and constantly look for innovation. At INBRAIN we believe in shared success and diverse ways of thinking, here you'll learn, grow, and advance in an innovative culture.WHAT CAN WE OFFER TO YOU?
- A collaborative environment where innovative ideas flourish and teamwork drives us forward. At INBRAIN, we believe the power of collective intelligence is unique. You will be part of a team that thrives on open communication, knowledge sharing and mutual respect. - Meaningful Work Impact: Our projects are not only exciting and challenging but also have a positive impact on the industry and society as a whole. You'll be part of a team that strives to create meaningful change. - Cutting-Edge Technology Exposure: Joining us means immersing yourself in the latest technologies and innovative solutions. You'll have access to state-of-the-art tools and resources, fostering continuous learning and keeping your skills relevant in a rapidly evolving industry. - Competitive salary (according to your experience/skills) - Internal flexible compensation scheme - Private Health Insurance - Training bonus for professional development and access to Udemy platform - 23 vacation days per year - Christmas week off - While we offer flexible working modality, because of the nature of this position, this will be an office-based position in Bellaterra for 2026 and in Barcelona at PCB from 2027.
Applications must be submitted in EnglishAt INBRAIN, we're not just offering a job – we're inviting you to be part of a transformative journey, Are you ready to transform lives? Join us!#diverseandinclusive We believe that a diverse and well-balanced workforce drives innovation. At INBRAIN, we foster the inclusion of all people regardless of culture, age, gender, sexual orientation and identity, or any other status
Text as published by Inbrain Neuroelectronics, S.L.. We don't edit postings; apply and ask questions on the employer's site.