Quality EngineerSenior Quality Engineer (mfd) Post Market Surveillance
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Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 portfolios 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 Bachelors degree (or equivalent) inEngineering 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 Germanlanguage 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.
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Travel Percentage: 10%Required Experience:
Senior IC
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
