Philips Quality Engineer 

Germany, Hesse 

97224685

Hold a pivotal position to disrupt Medtech and make a real difference for patients.

FORS is a unique technology that enables real-time 3D visualization of the full shape of devices inside the body without the need for fluoroscopy thus allowing us to break through the current limitations of image guided therapy by reducing the dependency on fluoroscopy while vastly improving the visualization of intra-body devices.

More about FORS:

Here you will establish and operationally execute quality strategies, based on a deep understanding of the quality management system processes as well as normative and regulatory requirements.
Your role:

• Ensures that appropriate Quality Plans are made that include all stages of the life cycle of the product and supports Quality Plan design
• Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system life cycle
• Performs independent technical assessment on product quality performance and post-market product quality analysis
• Can Lead quality related problem solving and root cause analysis during design and manufacturing
• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
• Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone

You're the right fit if:

• Rich experience in the field of design transfer and post-market quality assurance
• Rick experience in the field of manufacturing of Class III, sterile, (implantable) in-body medical devices.
• Rich experience in the field of document reviews, CAPA and improvement projects
• Preferable experience in working in venture / start-up setups incl. basic business understanding
• Preferable experience on reliability engineering
• Preferable experience on guide wires & sterile products
• Innovative mindset & entrepreneurial spirit, hands-on approach
• Excellent analytical and conceptual skills and structured way of working
• Passionate personality with outstanding communication and interpersonal skills

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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