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Principal Quality Professional  Medical Devices  

Leo Pharma (company)

Posted on : 11 April 2017

Project Description

Principal Quality Professional  Medical Devices

Become quality responsible in R&D projects and contributor to overall Quality framework

You will join Device & Packaging  an integrated part of Global R&D. After one year of existence we are now ready to take the next big leap forward, and we need you on our exciting growth journey. Together with a team of truly passionate and talented colleagues your focus will be Quality support to development projects in Device & Packaging and Quality Management System improvements. If you are looking for an opportunity to be part of a small and competent team where you can unfold your ideas and have massive impact, now is your time to act. 

Embedded software Quality expert and go-to-person across projects and in general  

As Principal Quality Professional you can look forward to a job with great variety of tasks concentrated within two main focus areas. On one hand, you will be Quality responsible for R&D Device projects with embedded software as a vital component. On the other hand, you will be a valued contributor to the creation of the overall Quality framework in Device & Packaging and at the same time influence the total Quality framework in the global organisation in LEO. Your primary tasks will be to: 

  • ­­­Deliver Quality support to development projects in Device & Packaging
  • Act as Quality Subject Matter Expert to highly skilled R&D colleagues
  • Contribute to the further creation of the overall Quality framework in Device & Packaging
  • Contribute to improvement of the Quality Management System
  • Drive and support implementation of actions related to changes
  • Plan and carry out execution of internal and external audits
  • Deliver product Life Cycle Management support 

+10 years  Quality experience from medical device R&D projects

You bring at least 10 years  experience within Quality assurance of electronic Medical Devices that combines hardware and software. Your career has provided you with knowledge of the below standards and directives:

  • Medical Device Directive 93/42/EC
  • Standards applicable for active Medical Devices such as ISO 13485, ISO 14971, IEC 60601
  • Standards applicable for Medical Device software such as ISO 62304
  • EMC Directive  2014/30/EU
  • 2014/53/EU Directive Radio equipment and repealing Directive 1999/5/EC
  • 21CFR part 11, 21CFR part 820 and other legislation as applicable  

Knowledge of Primary Packaging development and GAMP5 will be an advantage but not a prerequisite for applying. To succeed, you will need all your overview and attention to details. You must thrive on having multiple contacts and bring the good communication skills needed to come through with your agenda, also in English written and spoken.

Your new department

You will join 5 skilled and dedicated Quality Professionals. Our work environment is characterised by a high level of subject knowledge within our area of expertise. Knowledge sharing and helpfulness are some of our key virtues. We are based at the LEO headquarters in Ballerup, Greater Copenhagen.

We look forward to receiving your application.

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