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

SKILLS 🤹:

• Bachelor or Advanced 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
• Experienced in software quality engineering, quality assurance within regulated industries (medical device / in-vitro diagnostics / pharma)
• Technical expertise in software, systems development and development tools
• Experienced in the implementation of enhancements of Design Controls, development methodologies, and tool capabilities.
• Driven effective and correct implementation of the Risk Management process for medical devices during the entire product lifecycle.
• Track record of building and nurturing capabilities such as design, provision, and maintenance of software systems for document and data change control, product release, and complaint handling for digital health products.
• Knowledge in digital health standards and regulations: ISO 13485, 14971, IEC62304, 82304, 62366 and cybersecurity standards.
• English skills: fluent

TASKS & RESPONSIBILITIES 🚀:

• Represents Design Quality Assurance within the Global Q&R organization that supports the Company's Information Solutions portfolio, which includes medical device standalone software, focusing on product quality and achieving sustainable compliance.
• Performs Quality activities as required to meet the deparment's goals and objectives independently and leads through the performance of these activities. Able to identify improvements and implement them. Participate in cross functional Global initiatives.
• Covers tasks/projects with increased complexity and stakeholder management for the assigned software products project teams.
• Performs review and approval of design control documentation/deliverables for the department's medical device software during product development and product care activities. Deliverables including Product Risk Assessment, Design Verification and Validation documentation, among others.
• Ensures that any design quality issues that may jeopardize the regulatory status of projects and products are handled with the necessary priority and urgency.
• Participates in the planning of design control deliverables and/or project team outputs. Supports design and milestone reviews.
• Supports actions regarding CAPAs to ensure compliance with internal and external requirements.
• Participates in the definition and implementation of meaningful KPIs to ensure product quality is instilled during the software development life cycle.
• Prepare documentation for and participate in quality audits and inspections as applicable.
• Responsible as a Product Quality Team Representative in the Product Care Team

SCHEDULE 🕘:

• 08/09h -17/18h from Monday to Friday (flexible)
• 100% remote position

CONDITIONS 🌱:

• Salary package based on your profile. 
• Permanent Contract.
• Flexible Retribution Program (medical insurance, public transport ticket and childcare check)
• Discounts on gym network (Wellhub)
• Learning & Development.

Our goal is that you are well in every way!