Senior Quality Engineer - Design & Systems, Best, Noord-Brabant

Company
Our client is a technology company, focused on improving people's lives through meaningful innovations. With a century of history and more than 450 innovative products and services, their aim is to meet today's healthcare challenges through technology.
 
Job Description
As a Quality Assurance Specialist, you will play a vital role in ensuring the exceptional quality and reliability of innovative medical products designed to enhance and save lives.
 
Responsibilities

• Set and oversee Quality and Reliability targets for medical products, ensuring they meet high standards.
• Provide coaching and support to project teams to achieve quality goals.
• Collaborate with post-market teams to integrate feedback and enhance product designs.
• Define and manage patient and user safety strategies across product lifecycles.
• Develop comprehensive Quality plans for all stages of product development.
• Validate key design inputs and test strategies to guarantee product reliability.
• Lead quality problem-solving efforts and drive necessary design improvements.
• Serve as a subject matter expert on Design Control processes.
• Conduct thorough Design Reviews during product development phases.
• Analyze field data to identify trends and areas for design enhancements.

• Bachelor's/Master's degree in Engineering with 5+ years of experience.
• Background in Quality or Reliability Engineering, preferably in the medical or aerospace industry.
• Experience in problem-solving methodologies and risk management.
• Familiarity with medical device regulations and standards (e.g., ISO13485).
• Ability to lead Risk Management and FMEA activities.
• Strong skills in Design Controls, Verification & Validation, and Systems Engineering.
• Excellent interpersonal, communication, and project management skills.
• Willingness to work in an office setting at least 3 days a week.

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