Design Control Specialist for Product Development

If you are passionate about creating world-class products that helps improve the lives of people, then you might be exactly who we are looking for.

In the rapidly expanding Product Development area in ProInvent A/S, we are helping our clients develop the next generation of products through close collaboration and partnership. We utilize our highly professional skills to create innovative new solutions with a strong focus on customer needs, reliability, sustainability and manufacturability.

We are looking for a highly skilled Design Control Specialist who is ready to take the next step on an exciting career path and help our customers bring products faster to market by applying deep knowledge within Design Control documentation and Risk Management.

What we offer

We offer an exciting job in a dynamic company. There is a short way from thought to action, and here, creativity and structure go hand in hand. You will meet an inspiring and evolving everyday life with exciting professional challenges, committed colleagues and lots of job satisfaction. We have a unique culture where we help each other and have incorporated "forward-looking knowledge sharing". That is what develops us and makes us even better.

We will expect a lot from you, but in a healthy environment that prioritizes a healthy work/life balance. You are offered an attractive salary package, negotiated according to qualifications. In addition to your individually negotiated salary, you are offered a bonus scheme, overtime payment, Flex scheme, health insurance and pension.

What we expect

You are an experienced Design Control Specialist. You are proactive, structured and a self-motivated team player with a holistic mindset. You thrive by solving complex problems by using your own and your teams’ skills. You have the confidence and the courage to enter the client’s world directly.

As a Design Control Specialist, you will be responsible for generating and supporting design control deliverables and activities related to product development projects. The position requires knowledge of working in a regulated environment.

We are looking for a M.Sc. in a relevant scientific field, e.g. molecular biology, chemistry, pharmacy, nanotechnology or equivalent and we require that you have a minimum of 5 years of experience with design control activities for pharmaceutical, IVDs or medical devices.
Additionally, we expect you to have the following:

• Strong experience with Design Control documentation within Pharma and/or Medical devices
• Experience with leading Risk Management activities
• Experience with authoring and reviewing of Design Control documentation to support regulatory filings
• Experience with ensuring project deliverables are in compliance with QMS
• Experience with driving continuous improvement and optimization of design control processes and templates in collaboration with RA/QA
• Experience with cross functional project team work and collaboration with R&D, QA, RA, Marketing, Usability, and Manufacturing team members
• Computer proficient and skilled with Microsoft Office and typical file sharing platforms
• Excellent written and verbal communication skills in English.

 

Interested and qualified?

If the position as Design Control Specialist sounds like something for you, then please apply – we look forward to hear from you.

For more information and details on the position please contact Chief Development Officer, René Ferm Nyberg on +45 28 29 29 90
We will process applications continuously. Please submit your application and CV soonest possible.