Quality System Specialist
What we offer
Do you have a passion for quality systems? Do you want to play a key role in Widex A/S ensuring that our quality system is in compliance with standards and regulations?
Widex A/S offers you an exciting position in a company in transformation. The external requirements to the medical device industry are increasing. The challenge of this position is to ensure that Widex complies with relevant quality management system requirements and applicable device regulations.
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As Quality System Specialist your main responsibility is to assure that the documents in the Quality system are handled in a controlled manner. In your primary role administering document handling in the quality management system, you are a key person for Widex A/S in regards to maintaining compliance.
The Quality System Specialist reports to the VP of Global Quality System and Regulatory Affairs and will be part of a department of eight dedicated and quality conscious employees. Your place of work will be Lynge.
The main responsibilities are:
- Administration of the Quality Management System (QMS)
- Maintenance of the education plan related to the QMS
- System maintenance and development of the QMS
- Write and maintain selected QMS documents
- Handling of selected change requests
- Support, introduce and collaborate with colleagues in the Widex organization in regards to the QMS
- Act as internal auditor and follow up on issued non conformities
- Support during external audits
- Participate in delivering the Global Quality System (GQS) strategy and associated GQS plan
Ideally you hold a B.S. in Engineering or other related natural science disciplines (e.g. pharmacy, biology, veterinary, etc.) and have experience in QMS requirements e.g. ISO 13485, 21 CFR 820 and MDD. Preferably, you are an examined auditor (ISO 13485). You have min. 5 years of experience and a demonstrated record of accomplishment in a medical device or QA/QS function. 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 experience with control of documents and are a successful change agent with great experience of embedding quality focus and culture across the whole organization. The latter requires experience with education/training in Quality Management Systems (QMS) and regulatory requirements to the QMS. You are proficient in English and Danish on a professional level, both written and spoken and you master MS Office.
You have a personal commitment to delivering results. You are dedicated to quality and identifies and resolves problems in a timely manner. You have a very good eye for details but are also able to progress tasks in a good speed. You are a flexible, adaptable and robust person with great people - and facilitating skills and have a hands-on attitude with the ability to simplify, communicate and sell ideas across the organization. Further, you are able to plan and organize tasks and have the ability to work on several projects simultaneously. You are pragmatic with an open and communicative approach and with the ability to develop effective working relationships with employees at all levels. You are able to handle and deliver on routine jobs, while at the same you have the ability to move activities and people forward.
Please submit your application as soon as possible. We will screen and invite candidates for interviews on an ongoing basis. If you require further information about this position, please contact: Ellen Jespersen, VP Global Quality System & Regulatory Affairs, via email: firstname.lastname@example.org
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