Quality Assurance Engineer Job in Eindhoven, Netherlands

At Ajilon Professional Staffing, we are a leader in temporary and permanent recruitment and the placement of top talent. Our areas of specialty include organizational leadership and support positions in HR, non-clinical healthcare, office administration and more. We have the resources and the technology to offer job seekers and employers greater flexibility, making it possible for us to work with them in the way that works best for them.

We seek to completely understand the short- and long-term goals of our clients and candidates — this enables us to consistently act in their best interests. Through our job market insight and niche industry expertise, we help job seekers and employers find their best fit.

Quality Assurance Engineer Job Description

To provide Quality Assurance support technical leadership and oversight to ensure compliance with Quality System and regulations that govern product development activities within the Magnetic Resonance Imaging (MRI) department.

Your Responsibilities

• Design Assurance Quality Planning (i.e. new product development, design excellence, and design transfer).
• Actively participate in the design control process: planning, design input, design output, design review, design verification, design validation, design changes, and design history file maintenance.
• Apply appropriate risk management tools (i.e. FMEA's) throughout all projects and that the tools used are consistent with applicable regulatory standards and industry practices.
• Ability to effectively facilitate design reviews and requirements traceability activities
• Ensure the design history file is complete accurate and defensible for each product release
• Product quality planning through the use of quality control plans and product & process FMEA tools.
• Assure regulatory compliance by meeting or exceeding the requirements in accordance with FDA QSR's (21 CFR Part 820), ISO 13485, CMDR, MDD, J-PAL and ISO 14971.
• Give an advice for release for delivery: preparing release documents, issuing Standard Compliance Certificate (compliance to external safety / legal standards)) and put these data into the Agile system
• Work with the R&D team to measure and improve the design control process.
• Establish a dashboard of metrics, reports and statistical techniques that indicates the level of product quality at any stage of development or manufacturing
• Conduct quality audits planned in the Product quality plan and in the yearly audit program.

Quality Assurance Engineer Job Requirements

• You have a BSc in Engineering or Physical Science with a minimum of 5 years direct related experience in medical device industry
• Knowledge and understanding of FDA, ISO, and MDD regulations and project management and organizational skills

• 21 CFR820 (Quality Systems Regulation)
• 21 CFR 806 (Reports of Corrections and Removals Regulation)
• SOR 98-282
• ISO 9001; ISO 13485 / 14969 ; ISO 14971
• EN / IEC 60601-1 (2nd and 3rd edition)
• IEC62304 or GPSV; Software Validation
• IEC 62366 (Medical devices - Application of usability engineering to medical devices

• As a person you have strong interpersonal and influencing skills as well as analytical/Statistical skills.
• Fluent in English
• You are able to work under pressure to meet regulatory & company requirements and timelines.
• Professional and behavioral competencies required
• Adaptability & Flexibility
• Conflict management / Mediating Disputes
• Initiative
• Problem solving
• Persuasion
• Effort / Quality
• Stress Tolerance
• Listening
• Results Focus & Initiative
• Influencing Others
• Coaching & Mentoring (of peers / project members

Quality Assurance Engineer Application Information

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Quality Assurance Engineer Summary

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