As a Senior RAQA Specialist (m/f/d) you will oversee our Quality Management System at our Distribution sites in Germany, Switzerland, and Austria (GSA) to uphold quality and regulatory standards and elevate our level of excellence. Within our dynamic global team, your expertise will be pivotal in driving continuous improvement initiatives, all while enjoying the flexibility of work arrangements within our GSA region. Join us in shaping the future of quality assurance within a collaborative and innovative environment.
What will you do
You will partner with all departments and ensure that the Quality Management System is implemented and maintained in accordance with the requirements of the ISO 9001/13485 and the Stryker EU QA guidelines and procedures.
You will organize at fixed intervals, internal audits, but also formal Management reviews of the Quality System to ensure and monitor its suitability, adequacy and effectiveness.
You will address and evaluate customer satisfaction through the effective operation of the system, including continuous improvement initiatives.
You will be overseeing QA activities (Internal & external audit, SQM, NC/CAPA, Document Control, etc.).
What will you need
You have completed BS in Engineering, Science, or related degree and have not less than 5 years’ experience working OR you have completed MS in Engineering, Science, or related degree and have not less than 2 years’ experience working in RAQA for a Medical Device Organization.
You have proven experience in ISO 9001 / 13485 Quality Management Systems and MDD/MDR requirements, internal and external audits.
You are motivated to get involved in all areas of RAQA processes at the site(s) and already have experience in most topics (eg. NC/CAPA, process improvements, change management, etc.).
Your interest in people and your English and German language skills enable you to collaborate and partner with colleagues and stakeholders in the local GSA region but also globally with our manufacturing sites worldwide.
Additional information
Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence on site at our local location (s) should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
Your application
We are looking forward to your online application including all relevant documents such as CV, cover letter, transcript of results, and references. Please note to upload all attachments directly in our application procedure under the item "CV".
Please note that the internal job title may differ from the ad title.
Your contact:
In case you have further questions regarding the position, please feel free to directly reach out to Monika Ambroziak: monika.ambroziak@stryker.com
Travel Percentage: 10%More Information
Application Details
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Organization Details
Stryker
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