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!
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