Design QA Engineer (Medical Device Software) | Pharma (100% remote)

Ambit Iberia; Sant Cugat del Vallès; A distancia; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading company in the Pharmaceutical Sector is seeking a Design Quality Assurance Engineer to ensure product quality and compliance. With responsibilities ranging from managing quality activities to representing QA in global initiatives, this role requires strong expertise in regulatory standards and document handling in a remote position.

Servicios

Medical insurance

Public transport benefits

Childcare checks

Gym discounts

Learning & Development opportunities

Formación

• 3+ years of experience in digital health or related QA field.
• Experience in regulated industries (medical devices, pharma).
• Knowledge of ISO 13485, 14971, IEC 62304.

Responsabilidades

• Represent Design Quality Assurance in the Global Q&R organization.
• Manage quality activities independently and identify improvements.
• Review design control documentation and handle quality issues.

Conocimientos

Software quality engineering

Quality assurance

Risk Management

Technical expertise in software

Regulatory standards knowledge

English fluency

Educación

Bachelor's degree in science or software engineering

Descripción del empleo

We are looking for a Design Quality Assurance Engineer with experience in the Medical Devices Software industry for one of our clients in the Pharmaceutical Sector.

Skills:

• Bachelor's or higher degree in science, software engineering, or a related field.
• 3+ years of experience in the digital health industry or a related field within Quality Assurance.
• Experience in software quality engineering and quality assurance within regulated industries (medical devices, in-vitro diagnostics, pharma).
• Technical expertise in software, systems development, and development tools.
• Experience implementing enhancements of Design Controls, development methodologies, and tool capabilities.
• Proven ability to effectively implement the Risk Management process for medical devices throughout the product lifecycle.
• Experience building and maintaining capabilities such as software systems for document and data change control, product release, and complaint handling for digital health products.
• Knowledge of digital health standards and regulations: ISO 13485, 14971, IEC 62304, 82304, 62366, and cybersecurity standards.
• Fluent in English.

Tasks & Responsibilities:

• Represent Design Quality Assurance within the Global Q&R organization supporting the Company's Information Solutions portfolio, focusing on product quality and compliance.
• Perform quality activities to meet departmental goals independently, identify improvements, and participate in cross-functional initiatives.
• Manage tasks/projects with increased complexity and stakeholder engagement for assigned software projects.
• Review and approve design control documentation/deliverables during product development and care activities, including Risk Assessments, Verification, and Validation documentation.
• Handle design quality issues promptly to maintain regulatory compliance.
• Participate in planning design control deliverables and support design and milestone reviews.
• Support CAPA actions to ensure compliance with internal and external standards.
• Define and implement KPIs to promote quality during the software development lifecycle.
• Prepare documentation and participate in quality audits and inspections.
• Serve as a Product Quality Team Representative in the Product Care Team.

Schedule:

• 08:00/09:00 to 17:00/18:00, Monday to Friday (flexible).
• 100% remote position.

Conditions:

• Salary package based on your profile.
• Permanent contract.
• Flexible benefits (medical insurance, public transport, childcare checks).
• Discounts on gym network (Wellhub).
• Learning & Development opportunities.

Our goal is your well-being in every aspect!