Quality Engineer/Senior Quality Engineer (m/f/d) Post Market Surveillance

Work Flexibility: Hybrid or Onsite

Join Our Team as a Quality Engineer!

As a (Senior) Quality Engineer (m/f/d) in Freiburg, you manage complaints and adverse event reporting for Leibinger Instruments, ensuring safety and compliance as part of the Post-Market Surveillance team.

What you will do

• Investigate reported field cases, addressing both technical and clinical issues with input from relevant experts.
• Prepare and submit Adverse Event Reports according to EUMDR and FDA CFR 21, part 803 standards.
• Evaluate each case based on investigation results, risk assessments, and manufacturing data while collaborating with Quality, R&D, Manufacturing, Regulatory Affairs, and Clinical Affairs partners.
• Analyze data independently to identify failure modes, root causes, and trends.
• Participate in operational, cross-functional projects to improve products and act as the key contact regarding your product portfolio’s performance in the field.
• 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.

Travel Percentage: 10%