What we offer
Do you have a passion for quality? Do you want to play a key role in Widex A/S ensuring compliance to standards and regulations?
We offer 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 continuedly complies with relevant quality management system requirements and applicable device regulations.
As Quality Process Coordinator your main responsibility is to assure that the quality processes for non-conformity (NC) handling and customer complaints (CC) are followed. You are a key person for Widex A/S in regards to maintaining compliance.
The Quality Process Coordinator reports to the VP of Global Quality System and Regulatory Affairs and will be part of a department of nine dedicated and quality conscious employees. Your place of work will be Lynge.
The main responsibilities are:
- Screening of incoming CC’s and NC’s for potential risk
- For some CC’s and NC’s accessing and approval of plans for correction and corrective/preventive actions
- Follow up on open CC’s and NC’s to ensure timeliness
- Assessing fulfillment of plans and successive closing of CC’s and NC’s
- Support colleagues in the Widex organization in regards to use of the CC and NC systems
- Act as internal auditor / support during external audits
- Participate in delivering the Global Quality System (GQS) strategy and associated GQS plan
Ideally you hold a M.S. in Engineering or other related natural science disciplines (e.g. biology, veterinary, etc.) and have an interest in quality management system requirements e.g. ISO 13485, 21 CFR 820 and MDD. You have the ability to interpret and enforce regulatory requirements in a pragmatic way.
You have a passion for structure and are a successful change agent with experience of embedding quality focus and culture. It is an advantage if you have worked in a large organization, e.g. from a student related job and preferably you have experience with CC and/or NC handling. Possibly you have experience with medical devices from a QA/QS function with knowledge and understanding of associated quality standards and quality system requirements in medical device industry companies. You are proficient in English and Danish on a professional level, both written and spoken and you master MS Office. Experience with education/training is a plus.
You have a strong motivation to learn and a personal commitment to delivering results. You are dedicated to quality and identifies and resolves problems in a timely manner. 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 an 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.
If you have any questions in relation to the position, please contact VP Global Quality System and Regulatory Affairs Ellen Jespersen at firstname.lastname@example.org
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