Senior Quality Engineer - Risk Specialist-Medical Devices (m/w/
|Job Title:||Senior Quality Engineer - Risk Specialist-Medical Devices (m/w/|
|Location:||München (80335), Bayern|
|Salary:||€65000 - €90000 per annum|
|Contact Name:||Patricia Cioran|
|Job Published:||October 16, 2019 13:39|
Senior Quality Engineer - Risk Specialist
Passionate for Medical Devices?
Are you ready to take the next step in your career?
Keen to work with In-vitro Diagnostics?
Reporting to the Design Quality Manager, the Sr. Quality Engineer will support new product development (laboratory automation and related software) from a QA perspective.
This person will provide guidance to the core team to organize project structure and documentation to meet design control requirements, and support design changes to already established products.
Goal of the Position:
● Closely engaged in R&D projects towards introduction of new products as quality lead
● Partner with Risk Manager and Complaint Manager to ensure compliance
● Proactively provide guidance to maintain and improve compliance of development projects with global and local processes
What will be your tasks?
● Ensure conformity of the design process with applicable regulation
● Represent QA function within the core teams in charge of the development process
● Review and Approve design and development documentation related to the products you're in charge of
● Develop and execute validation plans and protocols
● Responsible for DHF completeness and maintenance
● Generate and maintain the risk management files
● Drive risk assessments
● Contribute to risk management activities: Identify sources of risk such as ergonomics, use error and risks associated with product characteristics
● Support post-market surveillance activities
Who you are: You…
● Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences
● 5 years+ experience within the regulated environment of in vitro diagnostics or medical devices
● Fluent in English - written and verbal
● Experience in design verification and/or validation and generation of associated protocols gained either from in house testing simulating end use or actual end use in a clinical environment
● Development process experience or practical experience with product verification and/or product validation
● Practical experience of workflows in laboratory environments is a plus
● Knowledge of EN62304, ISO14971, EN62366, EN61010
● High level of autonomy and critical thinking is required. Teamwork oriented.
● Computer skills (MS Office products)
What does this position offer to you?
● Competitive remuneration package
● Work for the top company in their field
● Fast-paced, intellectually intense, service-oriented environment
● Innovative projects with the latest modern tech-stack
● Diverse trainings and possibilities to grow and expand your skills
Do you want to know more?
Once you have applied with your CV (no letter of motivation is needed), we will be discussing all your interests and needs in detail. We will also contact the client in your behalf, introduce you to him / her and make sure that you are prepared very well for the upcoming interviews.
If the above-mentioned position doesn't match your needs, then I would suggest to contact me directly for what I have available.
● E-Mail: firstname.lastname@example.org
● Tel: 089 / 21 09 39 79
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