Senior / Staff Quality Engineer (m/f/d)
Senior / Staff Quality Engineer (m/f/d)
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Job Description
As a Senior / Staff Quality Engineer (m/f/d)working on Strykers cutting-edge surgery planning solutions youll play a vital role in shaping the future of pre-operative planning solutions ultimately improving patient outcomes. Join a company driven by its mission to make healthcare better and known for its culture of integrity accountability collaboration and innovation.
What will you do
Act as the Quality expert and independent interface between product development usability engineering regulatory affairs test labs and manufacturing throughout the full product lifecycle from concept through launch.
Lead and coordinate design control activities including risk management (ISO 14971) design reviews and DHF (Design History File) documentation.
Collaborate with cross-functional teams R&D Systems Engineering Usability RA and Software Engineers to identify mitigate and control product risks.
Guide project teams through the design control process holding them accountable to ensure quality is built into every phase.
Support and attend validation and usability studies including those involving customers to ensure risk controls are effective and compliant.
Provide quality leadership during the development of a new system/platform.
Contribute to continuous improvement initiatives and help ensure compliance with regulatory requirements including FDA MDR ISO 13485 and other relevant standards.
What will you need
Required Qualifications:
Bachelors or Masters degree in (Bio)Medical Engineering Electrical/Software Engineering or a related technical field.
2 years of experience in quality assurance or product development in a regulated industry (preferably medical devices).Based on years of experience the seniority of the role can be adjusted.
Proven knowledge of risk management (ISO 14971) and design control (21 CFR 820 / MDR).
Familiarity with software development and the software life cycle process (e.g. IEC 62304).
Strong communication coordination and analytical skills with a quality-first mindset.
Fluent in English; comfortable working in an innovative international environment.
Preferred Qualifications:
German language skills are a plus.
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
The position is initially limited to 18 months. Due to the large number of different positions and areas of responsibility Stryker often offers the options of being taken on in a permanent position.
Thanks to our flexible working hours model you will have the opportunity to work partially from the home office. However a regular presence of 3 days a week on site at our location in Freiburg should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
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Travel Percentage: 10%Required Experience:
Staff IC
Employment Type
Full-Time
