For our client we are looking for a highly skilled Design Control Specialist that are ready to take on an exciting career and help our customers brings products faster to market by applying their deep knowledge within Design Control documentation and Risk Management.

Our client is rapidly expanding their Product Development department, where they are helping clients develop the next generation of products through close collaboration and partnership. Our client utilizes the teams highly professional skills to create innovative new solutions with a strong focus on customer needs, reliability and manufacturability.

In this position you will be placed out at our clients customer as a Design Control Specialist in the greater Copenhagen area.

Professional qualifications:

You are an analytical 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 clients 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 3 years of experience with design control activities for pharmaceutical, IVDs or medical devices. Further we expect you to have the following:

  • Strong experience with Design Control documentation within Pharma and/or Medical devices
  • Experience with coordination of risk management activities
  • Experience with authoring and reviewing of design control documentation to support regulatory filings
  • Experience with ensuring that 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 Outlook, Word, Excel and typical file sharing platforms
  • You have excellent written and verbal communication skills in English.

Personal qualifications:

  • You are proactive, result oriented 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

Language & IT skills:

  • You have excellent written and verbal communication skills in English.
  • Computer proficient and skilled with Microsoft Outlook, Word, Excel and typical file sharing platforms

The company offers:

Our client offers 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. Our client has a unique culture where they help each other and have incorporated “forward-looking knowledge sharing”. That is what develops the team and makes them even better.

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 about the position please contact Birgitte Dyreborg on mobile +45 2034 9707

Please submit your application and CV soonest possible at bd@nordicsearchgroup.com

For at ansøge til dette job send dine informationer til bd@nordicsearchgroup.com