Quality Engineer (MIC)

工作内容

As a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 35.000 employees worldwide. Our European headquarters in Mechelen, Belgium covers a wide geographical reach (Europe, Africa, India, the Americas) and is home to Nipro Medical Europe, Nipro PharmaPackaging International and the Institute for Medical Practice (iMEP) Belgium.

To accommodate the growth of our new business unit Interventional Cardiology, we are looking for a hands-on Internal Auditor.

About the Role

The Quality Engineer shall take a leading role to ensure that Nipro plays a proactive role in post-market surveillance, working to actively gather information from post-market experiences with end users and ensure the safety and quality of our hemodialysis machines is always state of the art, addressing gaps through design and documentation updates, and if necessary co-ordinating field corrective actions. The Quality Engineer shall co-ordinate and lead these activities efforts with our internal stakeholders (RA/QA, R&D, Technical Services, Marketing) to ensure Nipro is effectively co-operating with the national competent authorities in charge of vigilance and market surveillance activities and meeting the applicable parts of MDR / regulatory compliance. In addition, these activities shall drive improvements in product quality to improve customer satisfaction.

What you’ll do

The primary activities of this role include

• Providing a structured approach to processing and handling customer complaints, aligned with internal stakeholders (RA/QA, technical services and R&D) and aligned with the QMS and MDR
• Proactively gather information and feedback from end users to assess for quality, safety and compliance risks and where necessary escalate risks for corrective action (design updates or technical documentation updates).
• Identify, analyze and assess safety and compliance risks within hemodialysis equipment. Based on this gap analysis, be able to propose measures that prevent safety and compliance risks.
• Communicate with both technical teams and senior management in Europe and Japan on quality compliance gap risks and countermeasures.
• Navigate the different QMS (local / global / development partners) to identify opportunities to improve QMS harmonization in line with ISO 13485 and MDR requirements

What you’ll need

• You hold a Masters degree in either electrical, mechanical, or biomedical engineering is required and have at least 4 years of relevant expertise in a comparable position
• You have thorough knowledge of ISO 13485, MDR and MDD,
• Experience with ISO 14971, IEC 60601-1 and IEC 60601-2-16 are highly desirable.
• Experience in dialysis machine development is a significant advantage, as well as quality tools such as Ishikawa, 5 WHYs, FMEA, SPC, Control Plans, etc
• The position will require regular travel on at least a monthly basis to Nipro’s headquarters in Mechelen, Belgium, or to our technical services office in Hamburg, Germany, as well as occasional travel to our offices in Japan. The Quality Engineer may otherwise work remotely from home.You exhibit excellent communication and collaboration skills
• You have an eye for detail and you are solution-focused
• Dealing with several topics, requests, and themes in the same day makes you feel alive
• You are proficient in Microsoft Office
• You have solid planning and time management skills
• Excellent command in English is required, additional languages are a plus

What we’ll Offer

We will offer the right candidate the ability to develop and grow fast in an international business setting. Next to a competitive salary, you will land in a friendly and dynamic working environment where people enjoy autonomy and taking initiative. Together with you and the team we want to develop this working environment to a great place to work that further attracts talents around the globe.