Project Quality Engineer

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About WS Audiology

WS Audiology was formed through the partnership of Widex with Singapore-headquartered Sivantos - two pioneers joining forces with one clear ambition: to expand hearing care for the millions of people with hearing needs.

Together, we can look back on a proud history of nearly 170 years of leading global innovation in the hearing aid industry. Today, the company employs more than 10,000 people worldwide, is active in more than 125 markets and generates more than 1.7 billion euros in revenue annually.

Learn about us on www.wsa.com

The team

The WSA QA R&D Quality team is a highly international team working closely together with the R&D department assuring that products are develop according existing processes and regulatory aspects.

We are driven by innovation and development so working with us is a constant learning curve. You will be located at our site in Lynge, Denmark with colleagues, who are highly skilled, passionate about our products and with a strong focus on teamwork to achieve our common goals.

You will report directly to our Head of Quality Assurance R&D.

The Role:

As the Quality Process Engineer in the R&D projects you will be:

  • Responsible for supporting a portfolio of R&D projects on quality
  • Making sure that the projects are working according to the latest standards
  • Working with our Regulatory affairs department to ensure that all requirements are well defined 
  • Working closely with the project teams to ensure proper document and PLM data quality
  • Working continuously to improve our global processes for a smooth and efficient execution.
  • Supporting the projects with overall best practices for project execution and product requirements
  • Supporting change boards for relevant project types where you are skilled in HW or SW Change boards
  • Supporting regular Audit sessions internal and external

 

You will be working in a highly international environment  and teams of R&D departments and Quality departments with global aspects over multiple geographical locations.

In this role you will have the following responsibilities:

  • To consult project teams on regulatory topics and assures the accuracy and completeness in all project documentations. Taking care of regulatory requirements
  • Perform document reviews and approvals with focus on compliance with processes, templates and formal issues.
  • Making sure that known experiences across projects and functions are brought to the attention of the project teams
  • Support regular Audit sessions internal / external
  • Participate in R&D Change Board Meetings and is mandatory for the release of an ECRM stages.
  • Contribution to the continuous improvement of our process for world class execution of medical device projects

About you

You most likely fit the following profile:

  • Strong Experience with development of medical devices
  • Structured and analytical mindset
  • Strong communication skills
  • Detail oriented
  • Experience with development processes including mechanics, hardware or Software/firmware
  • Preferred candidates have experience with ISO 62304 / ISO 13485 / FDA 21 CFR / MDR
  • Passionate about what you do
  • The corporate language is English, and you need to be fluent in English, both verbally and in writing.

Join WS Audiology

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 Jeppe Palmqvist+45 51 64 82 35 

We usually respond within two weeks

Or, know someone who would be a perfect fit? Let them know!

Lynge / Greater Copenhagen Area

Nymøllevej 6
3540 Lynge Directions

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