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Senior Design Quality Assurance Engineer | Pharma

Remote, Sant Cugat del Vallès·Added 3 days ago (last checked 10 Nov)

Ambit Iberia

15 open roles

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Our summary

Hours: Monday to Friday
Work mode: Remote, with limits
English: Required
Experience: 5+ years
Education: University degree

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Skills

Requirements

What we're looking for

Proven experience in quality and regulatory roles related to:
- Software engineering quality assurance
- Design controls and risk management
- Computer System Validation (CSV) for GxP-relevant digital health platforms
Strong knowledge of applicable regulations and standards, including:
- FDA QSR
- ISO 13485
- ISO 14971
- IEC 62304, IEC 82304, IEC 62366
- Relevant cybersecurity requirements
Broad technical understanding of:
- Software Development Life Cycle (SDLC)
- Systems engineering principles
- Cloud and SaaS platforms
- System integrations, data analytics, and data flows
Practical experience working in agile development environments (e.g., Scrum, Kanban, SAFe).
Excellent communication skills, with the ability to clearly explain complex quality and regulatory topics.
Strong influencing and collaboration skills within matrix and cross-functional organizations.
Proactive, solution-oriented mindset with solid business acumen.
Ability to navigate ambiguity and complexity while maintaining a strong compliance focus.
Coaching mindset, fostering capability development and continuous improvement.
High level of resilience, accountability, and flexibility in fast-changing environments.
Sound judgment, negotiation, and decision-making capabilities.
Ability to address conflicts constructively and build trust-based relationships.
Fluency in English, with the ability to communicate confidently and influence in complex, technical discussions.

Nice to have

5+ years of experience in Quality Assurance and Computerized System Validation (CSV) within regulated environments such as digital health, medical devices, IVD, or pharmaceuticals.

Education & certifications

Bachelor's or advanced degree in Science, Software Engineering, or a related discipline.

Pay & benefits

What you'll get

Salary package based on your profile.
Permanent Contract.
Learning & Development.

Our goal is that you are well in every way!

The role

We are looking for a Senior Design Quality Assurance Expert for one of our clients in the Digital Health / Life Sciences Sector.

What you'll do

Provide strategic quality leadership for digital health products and GxP-relevant software platforms throughout the full product lifecycle.
Ensure effective implementation and maintenance of design controls, risk management, and quality processes in software development environments.
Act as the primary quality interface between software development, digital infrastructure, data & analytics, and other cross-functional stakeholders.
Support and guide teams on regulatory compliance requirements for medical devices, IVDs, and digital health solutions.
Contribute as a Subject Matter Expert (SME) to design reviews, milestone reviews, audits, and regulatory inspections.
Oversee and support key quality processes, including documentation management, change control, product release, and complaint handling systems.
Provide quality oversight for agile development activities, ensuring compliance without compromising delivery speed or innovation.
Support the preparation and maintenance of validation and compliance documentation, including CSV activities.
Proactively identify quality risks and drive pragmatic, compliant solutions in complex and ambiguous scenarios.
Coach and support teams to strengthen quality culture, capability development, and knowledge sharing

How you'll work

08/09h -17/18h from Monday to Friday (flexible)
100% remote position
Some business travel may be required

About Ambit Iberia

Ambit Iberia is a specialized consultancy providing IT and engineering services to the pharmaceutical and life sciences sectors, with a strong focus on regulated environments. The company supports clients with digital transformation, data integrity, and compliance-driven projects, offering services such as system validation, MES engineering, cybersecurity, and cloud-based software development. Operating primarily in Spain and Portugal, Ambit Iberia positions itself as a niche partner for pharma companies seeking technical expertise in highly regulated settings.

With its main office in Barcelona, Ambit Iberia serves as the Spanish arm of a broader international group, delivering projects across Europe. The company's work culture emphasizes technical excellence and regulatory compliance, making it an attractive option for international professionals with backgrounds in pharma IT, validation, and engineering. Many roles are offered as fully remote or hybrid, allowing flexibility for candidates based in Spain or Portugal, and the company actively seeks talent with experience in GxP environments and modern cloud technologies.

Industry: Health
Employees: 160
Headquarters: Barcelona, Spain
In Spain: Barcelona

Good to know if you are moving

Ambit Iberia offers fully remote positions for some roles, allowing flexibility for international professionals based in Spain or Portugal.
The company specializes in the pharmaceutical sector, providing opportunities to work on regulated systems and compliance-driven projects.
Barcelona, where Ambit Iberia is based, is a major European hub for life sciences and technology, offering a vibrant professional community.
Roles often require expertise in GxP, MES, and cloud technologies, making it a good fit for specialists in pharma IT and engineering.
The company's international group structure may offer opportunities for cross-border collaboration and career growth.

All open roles at Ambit Iberia