Design Quality Assurance Engineer

Sonova International; Alicante; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A leading global medical device company in Alicante seeks a Design Quality Assurance Engineer to ensure innovative products meet safety and performance standards. Collaborate with R&D teams through the product lifecycle and apply your expertise in risk management and quality assurance in a pivotal role. Ideal candidates have engineering degrees and experience in regulated industries. Fluency in English is required.

Formación

• Proven practical experience in a regulated industry, preferably medical devices.
• Knowledge of ISO 13485 and ISO 14971.
• Hands-on experience with design control, product risk management and design FMEA.

Responsabilidades

• Support design control activities for new development projects.
• Perform risk management activities for assigned projects.
• Collaborate with cross-functional development teams.

Conocimientos

Test Cases

Performance Testing

Quality Assurance

Agile

Debugging

Jira

Selenium

Educación

Bachelor's or master's degree in engineering science

Herramientas

MS Office

Visio

Project

Polarion

Descripción del empleo

Join Sonova's global quality team and play a key role in ensuring our innovative medical devices meet the highest standards of safety, performance, and compliance. As a Design Quality Assurance Engineer, you'll partner with R&D teams to guide product development from concept to launch, ensuring regulatory excellence every step of the way.

Key Responsibilities

• Support design control activities for new development projects (Hardware / Software)
• Perform risk management activities for assigned projects
• Support with design FMEA activities
• Actively collaborate with cross-functional development teams
• Support design changes and post-launch improvements
• Contribute to continuous improvement projects

Your Profile

• Proven practical experience in a regulated industry, preferably medical devices
• Bachelor's or master's degree in engineering science; quality is a plus
• Knowledge of ISO 13485 and ISO 14971
• Hands-on experience with design control, product risk management, and design FMEA
• Hands-on experience with software development (IEC 62304 / IEC 60601 series is a plus)
• Proficient in MS Office; experience with tools like Visio, Project, or Polarion is a plus
• Fluent in English

Key Skills

Test Cases, Performance Testing, Quality Assurance, SOC, Agile, Debugging, Jira, Perl, Software Testing, Test Automation, Scripting, Selenium

Employment Type : Full Time

Experience : [Specify years]

Vacancy : 1