EXO ARNVIND is looking for a Product Quality Engineer R&D to our customer – a world-leading medical device company in their field.
Do you want to drive product quality and support the development of innovative products that improve people’s lives? Do you want to join a world-leading company specialized in the treatment of chronic diseases such as diabetes and Parkinson’s Disease?
Then you might be the Product Quality Engineer we are looking for.
Our Customer is growing and transforming their business for the better. Better products, better ways of working, and better ways of delivering for their customers. They are aiming for nothing short of excellence.
About the role and your key responsibilities
You will be responsible for risk management and for meeting regulations and internal procedures – within one or more product development projects. In close collaboration with their customers, they develop and deliver customized product variants for their key customers. These projects are characterized by a short development cycle, typically 9 to 18 months. In some projects, they develop new innovative products or may do so in a combination of both.
We can offer you a central role in an exciting company in constant growth, where you will have a great influence on the projects and processes.
You will be a part of a team of 10 highly competent colleagues responsible for the design control process and activities, technical documentation, product quality, and their PDM system.
The work location is Greater Copenhagen. You can expect up to 15 travel days annually.
Within one or more product development projects you will be:
- Responsible for risk management (use, design, and process), DMR, and GSPR within one or more product development projects
- Involved in all project activities, through review and approval to ensure standard operating procedures and instructions are followed and documented with high quality according to their QMS as well as meeting external standards and regulations
- Involved in assessing, developing, and improving the standard operating procedures, instructions and templates in the context of risk management and product development
About you
We are looking for a Product Quality Engineer with excellent communication skills, a high business acumen and a solid experience within product quality, design control, and good documentation practices.
You understand that key contributing factors to success are collaboration – and at the same time deliver high quality and timely solutions and deliverables. You are well structured and methodological and know when to execute and delegate, and how to make the right prioritizations.
To be truly successful in this position you are acting as a team player and build a strong collaboration with other functions like QA, RA, Process Engineering, and Production. You also have a high level of language
skills in English, both written and verbal.
Qualification & Experience
- You hold a Master or bachelor’s degree in engineering, technical science, or similar
- Minimum 3 years of experience in Medical Device product development (Class II)
- Hands-on experience with Design Control in accordance with EU ISO 13485, US 21CFR820 Quality Systems for Medical Devices, and MDR
- Experience with requirements engineering, product risk management, and usability engineering
- Knowledge within regulatory legislation and standards
About our customer
We offer you a position in a dynamic and global company where the days are never the same. Our customer will provide you with challenges and development opportunities and the chance to influence your own role. You will be a part of a great community where we all help and support each other – while continuously building on competencies and network.
Our customers’ ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work.
You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it. This is stepping up to a challenge. This is work that’ll move you.
Our customers’ vision is to develop pioneering trusted medical solutions to improve the lives they touch. They devise, develop and manufacture innovative products and services that support people with deeply personal and challenging medical conditions, helping to improve care for
them and giving them greater confidence, freedom, and mobility.
Our customer is part of a global medical technology business focused on serving people and caregivers. They develop and market sterile disposable products for subcutaneous infusion of various medications. Specialized in the treatment of chronic diseases, such as Diabetes Mellitus and Parkinson’s Disease. Their manufacturing facilities in Denmark and Mexico produce more than 100 million infusion sets per year, making them the world leader within this field.
If the above descriptions could be you – then please apply here at Open Positions
We look forward to hearing from you
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We look forward to working with you!