Corporate Quality Technical Lead (Medical Device)

WE ARE HIRING!

CORPORATE QUALITY-TECHNICAL LEAD (MEDICAL DEVICE)

Neuraxpharm is looking for people who want to make a difference and improve patients’ lives within the CNS area. We want individuals who will go the extra mile and make great things happen.

Being part of this team does not mean you are just working for a company, but for a cause!

Neuraxpharm is seeking a Quality & Technical Lead – MedTech to strengthen our MedTech Business Unit, based in Barcelona (hybrid).

Your mission:

Reporting to the Head of Quality and dotted to MedTech BU, this role offers an exciting opportunity to lead Quality and Technical Operations for Neuraxpharm’s growing MedTech portfolio.

You will ensure that new product and software releases are deployed safely and compliantly, while driving excellence across Quality Management Systems (QMS), post‑market processes, partner governance, and technical documentation.

Your contribution will be key to ensuring compliance, operational robustness, and high performance in a dynamic and expanding environment.

Your major accountabilities:

1. New Tech & Product Introduction

• Coordinate and monitor partner‑led deployments of new software, firmware, and hardware releases, ensuring clear validation gates, test evidence, and rollback plans.
• Lead quality verification and acceptance prior to product or release launch (release notes, test reports, defect lists, traceability matrices).
• Plan and execute audits and technical due diligences of MedTech solutions, partners, and suppliers; define gaps and follow‑up actions.
• Evaluate new MedTech alternatives from technical, quality, and operational perspectives.
• Define and agree Quality Technical Agreements (QTA) and QMS interaction models (change control, documentation, deviations, CAPA).
• Assess partner manufacturing readiness, including process validation, UDI/traceability, inspection & test capabilities.
• Ensure compliance by design with MDR and GDPR in collaboration with Regulatory and Legal teams.
• Coordinate the creation and maintenance of Technical Documentation, IFUs, HTA inputs, labelling, and declarations.

2. Quality & Operational Governance

• Own the Quality Plan for the MedTech portfolio, driving continuous improvement across internal and external stakeholders.
• Define and monitor quality KPIs (complaints, NC/CAPA cycle time, audit closure rate, FPY/PPM with partners, documentation control).
• Supervise post‑market surveillance (PMS/PMCF) activities with Regulatory, ensuring proper signal detection and escalation.
• Prepare operational and quality documentation for tenders and market access dossiers.
• Support Regulatory to ensure MDR / ISO 13485 compliance across processes, design change control, and vigilance inputs.
• Contribute to submissions to Notified Bodies and National Healthcare Systems, ensuring consistency and quality of deliverables.

We Would Like You to Have:

• Degree in Engineering, Life Sciences, Quality or related fields. Auditor certification (ISO 13485), CQE, Lean/Six Sigma, or PMP is a plus.
• + 5 years of experience in Quality or Technical Operations in Medical Device, covering product/release introduction and post‑market quality. Proven experience in audits, technical documentation, and manufacturing readiness assessments.
• Experience establishing and governing QMS and QTA models with external partners.
• Strong knowledge of MDR and ISO 13485, plus familiarity with ISO 14971 and software lifecycle/validation standards (IEC 62304 / CSV).
• Strong analytical mindset with experience developing quality KPIs and dashboards (Excel / Power BI). Openness, and the ability to operate effectively in a dynamic and evolving MedTech environment.

• Excellent stakeholder management across RA, Legal, IT, Operations, Market Access, and external partners.

• Fluent English; ability to collaborate across geographies in multicultural settings.
• Availability to travel up to ~10%.

ABOUT US

Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.

Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline and acquisitions.

The company has c. 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira.

Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals in Spain.

Be part of the team where you can count on us to deliver:

• Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
• Attractive remuneration according to the experience and skills provided.
• An inspiring leadership team that drives performance.
• An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, dynamic, a result focused and an expert & excellent team!

Interested in knowing more?

Have a look at what Neuraxpharm culture represents and what makes us a great place to work: www.neuraxpharm.com

If you want to join us, this is your opportunity!

WE COUNT ON YOU, YOU COUNT ON US

At Neuraxpharm’s we ensure an inclusive, diverse, safe and respectful work environment for everyone in its organization. As we care for our people as much as we do for our patients, we are committed to guaranteeing a healthy, inclusive and equal opportunity workplace that enables employees to develop their professional potential, while ensuring their individual and collective satisfaction.

We are guided by a Diversity & Inclusion policy to ensure a business culture based on the principles of diversity, equality and inclusion. Our policy complies with European legal regulations and includes the necessary standards, processes and measures to be taken in the event of discrimination or harassment against any employee of the company.

We embrace and promote different cultures, gender identities, seniorities, ages and mindsets within the workplace, to bring different perspectives, styles and experiences to our business.