Quality EngineerSenior Quality Engineer (mfd) Post Market Surveillance
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Join Our Team as a Quality Engineer!
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 Leibinger Instruments 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 FDAs 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 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
