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. Thus, the challenge of this position is to ensure that Widex complies with relevant quality management system requirements and applicable device regulations.
As Quality System Specialist your main responsibility is to assure that product changes are handled in a controlled manner. Your primary role is to administer and develop the process for handling product changes. As head of our Change Board, you are a key person for Widex 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 in Lynge, north of Copenhagen.
The main responsibilities are:
- Head of Change Board and administration of the product change system
- System maintenance and development of the product and process change processes
- Project management for assigned Global Quality System (GQS) tasks to assure the Quality Management System (QMS) reflect Widex needs and is compliant with Regulations
- Write and maintain selected QMS documents
- 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 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. five 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 system requirements in medical device industry companies - both from Europe, US and other major markets. You have the ability to interpret and enforce regulatory requirements in a pragmatic way.
You have experience with Quality Management Systems - it is an advantage if you have hands on experience with change control. You are a successful change agent with great experience of embedding quality focus and culture across a 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 but are also able to take on tasks new to the organization where you in collaboration with colleagues have to be innovative in finding solutions. 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
Please write in your application that you've seen the job at Jobfinder