Quality Assurance Engineer

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We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.

We currently have the following opportunity available - please contact us for more details!

The core task of the Quality Assurance Engineer is to ensure compliance to the current standards and regulations that apply to the Medical Device Industry. As member of a team of QA engineers, you will collaborate with functional teams in different disciplines to develop medical devices, drive processes and host audits.

As a Quality Assurance Engineer, you will play a critical role in ensuring that the products and processes of our Business Line Brachy products are safe and effective and meet the required regulatory standards. You will be part of the QA team (3p) and together with the Regulatory team (3p), both teams form the RAQ department. These teams collaborate with other functional teams in areas such as Engineering, Order Fulfillment, Sales & Marketing, and Manufacturing Engineering.

• Ensure product compliance of an assigned value stream (e.g. applicators and materials used within brachy medical devices)

• Support the local and global Quality Management System (QMS) and processes

• Represent QA organization in specific processes (NC, CAPA, complaints) or other functions with technical expertise (e.g.  Order fulfilment, Manufacturing, etc.)

• Ensure accurate reporting and documentation for quality assurance processes

• Analyze process data and trends to drive optimization

• Participate in external audits for regulatory authorities and Notified Bodies

• Participate in the execution of the internal audit plan.

Main focus will be to ensure our Xoft products and processes, as managed through the San Jose site, are in compliance.

What you bring

• Bachelor’s degree in Engineering or equivalent or a related field or a formal engineering apprenticeship with demonstrated experience in a similar role.
• Training and experience in relevant medical device regulatory requirements and standards (e.g. ISO, IEC, MDD, MDR.]
• Proven experience in relevant areas of Quality, Regulatory or Engineering, preferably within a medical device environment.
• Strong written and verbal communication skills and ability to collaborate effectively.
• Objective driven and customer focused. Capable of producing results working unsupervised under own initiative.
• Professional integrity.
• Able to translate regulations into meaningful business requirements.
• Possess a structured approach to problem solving with an appreciation of quality tools & techniques.
• Must be an effective team player with the ability to mentor, lead and problem solve to provide solutions to the business.
• Confident and open personality who is able to communicate effectively, both written and orally with people at all Ievels.
• Ability to work efficiently under tight timelines.
• Proven fluency in English and other applicable languages relevant to their specific geographies.
• Quality professional certifications preferred.
• Experience in quality improvement tools and techniques is a plus (e.g. Lean, Six Sigma, DOE, Statistical Methods, etc.)
• Travel may be required.