As a (Senior) Quality Engineer (m/f/d) you will be responsible for Adverse Event Reporting, focusing on MDRs, as well as playing a crucial role in Stryker Craniomaxillofacial’s Recall/FSCA processes, ensuring product safety and compliance within the global regulatory Post Market landscape. 

 

What will you do 

• You will be responsible for creating and submitting MDRs in compliance with FDA’s CFR 21, part 803 requirements (Medical Device Reporting).

• You will review, assess and keep overview of all incoming and open product complaints that need to be evaluated for reportability in order to ensure reporting in the required timeframes.

• You will be closely collaborating with clinicians and other Post Market Functions in order to accurately assess reportability decisions in line with the associated (medical) risk assessment. For events that do not meet reporting criteria, you will compose a comprehensive rationale for not reporting the event.

• Furthermore, you will be responsible for managing commercial holds as well as driving subsequent assessments to determine if further activities such as Recalls/FSCAs are required

• You will be responsible for preparing and coordinating Recalls/FSCAs in compliance with regulatory requirements.

• As part of these processes, you will maintain communication with our partners from Marketing, Production, Sales and other functions.

What will you need 

• You have a Bachelor’s degree (or equivalent) in Engineering, Science, or related degree.

• You have 0+ years of experience in medical technology, pharmaceutical industry or other regulated environment. Depending on years of experience and skills, the role can be adjusted to a more senior level.

• Ideally you have demonstrated knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, submission, registration, obtaining approval, documentation, compliance, post-marketing surveillance/vigilance and distribution.

• You have strong technical writing, coordination, and execution skills, with excellent communication, collaboration and autonomous decision-making.

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

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 on site at least once per week at our location in Freiburg 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.