WS Audiology combines over 140 years of experience in pioneering better solutions to help people with hearing loss. With a passion for impact, our around 12.000 employees are committed to achieving our purpose: wonderful sound for all. With brands like Signia, Widex, Audio Service, Rexton and Vibe, and with diverse assets across wholesale, retail, online, managed care and diagnostic solutions, we are active in over 125 markets. Going beyond together, we achieve annual revenues of around EUR 2 billion.
WS Audiology continues to grow as the market leader in the hearing aid industry, by bringing innovation and the best quality in our products to the markets. We are driven by the passion to improve the quality of people’s lives by bringing in innovation to the hearing aid industry.
Quality is the key pillar in ensuring strict regulated requirements, safety rules and procedures are compliant with what we do and deliver. As our new Quality Specialist, you will be joining our team in Lynge and reporting to our Director of QA OPS, you will be the Quality representative to our departments (Operation, Production Engineering, Supply Chain, and R&D) on quality topics. The focus will be on preparing trend reporting, and data analysis.
The current department in Lynge consists of 6 skilled colleagues and beyond that, you will work closely with your colleagues at the production sites in Singapore, the Philippines, China, the US, and Poland.
You will be Quality Representative to ensure/maintain manufacturing process compliance and product manufacturing quality.
Support production and other partners with quality data thru statical analysis to drive continuous improvement on products and processes using e.g., SMART Lean. Work with SPC as sparring partner for Production.
Maintain product Quality standards acc. to QMS, ISO 13485, FDA QSR, and procedures with the goal of meeting regulatory compliance and ensuring customer satisfaction.
Furthermore, you will have the following responsibilities
- Handling of non-conformities within the frame of a customer complaint, NCR, and CAPA incl. root cause analysis in partnership with production specialists
- Support operations by solving – and documenting solutions to quality issues
- Review and approval of quality-related documents e.g., QMS instructions, pFEMA, and validation.
- While doing improvements in operation ensuring compliance towards required standards
What we look for in you
We are looking for an open-minded and pragmatic candidate with at least 1 year of experience in the quality area. You are the ideal candidate if you had a chance to work in a manufacturing environment and possess knowledge of production quality – we’re looking for an outgoing candidate ready to closely collaborate with production staff. We expect from our candidate analytical skills, a proactive approach, and a willingness to learn and to become an expert in operations quality.
- Failure Mode Effect and Analysis (FMEA); Root cause investigation techniques awareness
- Statistical Technique/Analysis including Statistical process control (SPC).
- Knowledge and understanding of ISO 13485/MDR, 21 CFR 820, and quality systems requirements in the medical device industry companies would be highly appreciated
- Good technical understanding
- Experience with writing procedures/instructions
- Experience with LEAN
- Fluent in English – both written and spoken and have knowledge of Danish
- Familiar with Microsoft Office – Word, PowerPoint, Excel, and IT in general
- Strong communication skills and willingness to improve the experience in the quality of medical devices production
- Analytical by nature, but also pragmatic in solutions
- Ability to work in a systematic and structured way
- Passionate about compliance and record keeping - identifies and resolves problems in a timely manner
- Enjoying having a broad interface in a large international organization
- Proactive by nature and LEAN mindset
- Follows through on commitments and pays attention to details
- Hands-on attitude, be flexible and show a positive attitude to colleagues requesting assistance.
- Robust, patient, and persistent when following up on outstanding documentation
What we would like to offer you
The working environment at WS Audiology is informal with helpful and skilled colleagues. Our mentality is result-oriented, and we focus on creating the best possible products and always improving competencies. You can expect a working culture with a large degree of freedom under responsibility, where it is, and what you deliver in the end that counts.
Our values focus on teamwork across functions, pioneering as well as having the motivation to make an impact. So, if you can see yourself in those values, you will fit right in.
The benefits we can offer include an advantageous pension scheme with health insurance, a sports and arts club, and good canteen facilities.
Our Danish headquarter is based in an almost CO2-friendly and modern facility with beautiful surroundings close to Allerød north of Copenhagen, Denmark.
Come join us
If we have caught your interest, please do not hesitate to send your CV, no application needed, our way. We will screen and invite candidates for interviews on an ongoing basis.