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What we offer
We are looking for a new colleague in Global Operation Quality to support our continued effort of improving the quality of supplier deliverables to our production sites. You will play a key role in our effort to secure that the quality of our products is on a continued high level. 
 
Global Operation Quality is the department with the overall responsibility for QA, QC and SQM in Operations locally and globally. You will report to Director of Global Operation Quality and have a dotted line to Director of Global Sourcing. In Global Operation Quality, we are 14 colleagues, incl. one person in SQM who will work in close cooperation with the new Supplier Quality Specialist.  
 
We have a high level of cooperation with our production sites in Estonia, Poland and our suppliers mainly in the Far East. 
 
We are situated in our headquarters in Lynge, where we also have production facilities. 
 
Your Responsibilities 
You will act as contact person to the suppliers regarding quality issues. This includes relationship building with key partners, negotiating and implementing sustainable quality contracts in close collaboration with Global Sourcing. As part of this, you plan and execute site visits and supplier audits. 
You will participate in selecting, approving and evaluating suppliers from a quality point of view in cooperation with Category Managers. You must ensure timely handling of NCRs towards the suppliers. 
 
Tasks:  

  • Handling of NCRs related to supplier issues 
  • Responsible for creation and maintenance of Quality Agreements 
  • Maintenance - and approval of Supplier List 
  • Creation and maintenance of supplier audit program 
  • Conducting supplier audits and following up on those 
  • Development and maintenance of procedures and instructions related to the requirements in ISO13485 and 21 CFR part 820 etc.  

 
You  
Ideally you hold a B.Sc. in Engineering or other related natural science disciplines (e.g. mechanics, electronics etc.) and have experience in QMS requirements e.g. ISO 13485, 21 CFR 820 and MDD/MDR. Preferably, you are an examined auditor (ISO 13485). You have minimum three years of experience within SQM and a demonstrated record of accomplishment in a medical device or similar function from another industry. Further, you have knowledge and understanding of quality standards and quality systems requirements in medical device industry companies - both from Europe, US and other major markets, and the ability to interpret and enforce regulatory requirements in a pragmatic way.   
 
You have an analytical approach to the assessment of the closure of non-conformities and corrective & preventive actions and have experience with control of documents. You have solid experience of working internationally and in different cultures. You find it interesting to travel and are willing to have up to 40-50 travel days. You are pragmatic with an open and communicative approach with the ability to develop effective working relationships with colleagues and our suppliers. As a lot of improvements and changes are taken place in Widex it must motivates you to work in this environment. You can work independently as well as in teams and you are result orientated. 
 
On a professional level, you are proficient in English and Danish, both in speech and writing and you master MS Office.  
 
Join Widex 
Please submit your application as soon as possible but no later than March 8th, 2019. We will screen and invite candidates for interviews on an ongoing basis. If you require further information about this position, please contact Susanne Røssel Petersen, Director of Global Operation Quality, via email: susp@widex.com  

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