As a Lead / Staff Quality Specialist (m/f/d) Quality Management System (QMS), you will play a critical role in developing and maintaining our Quality Management System (QMS) to meet regulatory requirements for medical devices. You will ensure that Stryker's QMS is both effective and efficient, securing regulatory clearances and certifications. Your expertise in identifying root causes, driving continuous improvements, and collaborating across functions will be essential in enhancing our quality standards and supporting our mission to make healthcare better.

What will you do

• You will ensure compliance of the Quality Management System (QMS) with internal and external regulatory requirements across Site, Division, Corporate, including MDSAP, EUMDR, ISO, and individual country standards.

• You will continuously develop and optimize the future state of the QMS to align with evolving business needs but ensuring efficiency and effectiveness of the QMS

• You will uphold awareness of applicable standards and regulations, and monitor activities to keep the QMS robust and adaptable to changing regulatory landscapes.

• You will serve as Subject Matter Expert (SME) and manage day-to-day quality processes, including assuring effective management reviews, internal auditing and facilitating discussions and decisions critical to QMS enhancement.

• You will assess and quantify daily QMS requirements, optimizing its structure to support operational excellence and regulatory compliance.

What will you need

• You have completed BS in Engineering, Science, Business or related degree; or 6+ years of equivalent experience required.

• You have a minimum of 5 years’ experience in a manufacturing environment, preferably in the medical device or another regulated industry.

• You have experience interacting with regulatory agencies in a regulated environment and ideally possess thorough knowledge and understanding of US and international medical device regulations.

• You have strong knowledge of Quality Systems, including but not limited to Quality Planning,  Quality Reviews, Document Management and Audit processes.

• You are highly organized, detail-oriented, and an excellent communicator.

• Your English language skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office. German language is a nice to have.

Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity. 

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 of at least one day a week on site at our location 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: E-Mail schreiben