About the role
Driven by the passion to improve quality of people’s lives, WS Audiology continues to grow as market leader in the hearing aid industry, by bringing innovation and best quality in our products.
With solid QA manufacturing experience within Medical Device, you can become part of the WS Audiology journey to make wonderful sound for all.
As a QA Specialist you will be part of important processes, where you will be one of the quality department's representatives and contributing to the maintenance of WS Audiology compliance level, with a special focus on NCR/CAPA handling, documentation and QA support in production area. In the position you will refer to the Director of QA Operations.
QA Operations is responsible for QC, QA and SQM globally and the department employs 12 employees. You will be part of the relatively newly established QA team, which currently consists of 5 employees, all of whom have a close cooperation with both R&D, the ´Project and Process' department and the production units in Denmark and Poland. In addition, there is a great cooperation with our production partner in Poland, Singapore, China and Philippines.
We are certified in accordance with ISO 13485:2016 and comply with FDA QSR CFR 21 part 820 requirements as well as other global relevant standards.
- NCR/CAPA actions incl. root cause analyses and risk assessments
- Support to production within quality related tasks
- Perform quality training in production regarding improvement activities
- Creation, review and approval of documents (Procedure, instructions, work instructions, NCR, etc.)
- Support establishing sampling plans for QC incl. statistics related to these
- Quality representative from Operations in Design transfer (from R&D to Operation) to ensure appropriate implementation of new products/processes in production
- Carry out regular check for process compliance to work instruction and Standard Operating Procedures and identify areas of improvement
- Support production with compliant handling of DHR (Device History Records), traceability of document and storage of those
- Perform internal auditing
The successful candidate is an experienced QA specialist, with outstanding standards to quality and strong understanding within the whole value-chain within production and manufacturing.
- Degree in engineer/technician/laboratory technician or other relevant educational background
- Min. 5 years of experience working with QMS - especially within ISO 13485, 21 CFR 820 and MDD/MDR is preferred, but not a must
- Strong experience with documentation requirements, preparation of documents and NCR handling
- Strong experience with QA in production
- Strong Danish and English skills in speech and writing
- Experience working in an international company within production and manufacturing
- Flair for IT and have knowledge of MS Office and ERP systems
- It is an advantage if you have experience with change management
- You thrive working with routines and high standards - as well as optimization tasks
- You are driven by achieving results in a pragmatic way
- You're flexible and want to go the extra mile
- You have the ability to motivate colleagues to work with new processes
- You thrive in an informal culture, with short decision-making paths and having freedom with responsibility
- You are able to plan your own work, work in a systematic and structured way and manage many projects without losing track.
- You have a sense of quality and detail while seeing things in a larger context
- You are good at building relationships and communicating at all levels of the organization
- You have a positive mind-set and a good sense of humor
About WS Audiology
Formed in 2019, through the merger of Sivantos and Widex, WS Audiology combines over 140 years’ experience in pioneering the use of technology to help people with hearing loss hear the sounds that make life wonderful. We are active in over 125 markets and employ 11,000 people worldwide. Our broad portfolio of hearing related products and services generates annual revenues of around EUR 1.7 billion.