Design Quality Assurance Expert (m/f/d)
This role combines the Design Quality Assurance and the Product Center Manager role. In your role as Design Quality Assurance Expert (m/f/d) you will be working as a part of product development team on new product development or on design changes to ensure product quality and reliability, minimize risk to users and patients. In addition, the Product Center Manager's responsibilities are added to this position, which includes post-market surveillance tasks and ensuring regulatory compliance. This ensures that the entire life cycle of the product can be managed and controlled.
Your assignments
Design Control
- Ensure that all design control deliverables comply with applicable regulatory requirements and design control processes
- Guide engineering and other teams and ensure that design control requirements are being met in an effective manner to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review
- Provide input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF files for accuracy and completeness and provide guidance on FDA compliance and procedures
- Work independently on high visibility new product development projects; including projects involving multiple technologies and design sites
- Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards
Product Conformity
- Main contact for medical devices marked with the CE-mark with a focus on non-active medical devices for Peritoneal Dialysis
- Ensure that Technical Files are complete and up to date and that essential requirements are met
Post Market Surveillance
- Analyze PMS data and if needed initiate required activities
NC/CAPA
- Acts as a Quality Approver for design control related topics and as a Quality Assignee for system related topics
Your profile
- Bachelor or master’s degree in engineering or a similar technical field required, such as medical technology or a technical apprenticeship with further training to be a technician, along with relevant professional experience
- Several years related experience or an advanced degree without experience
- Advanced knowledge of Design Control and Risk Management standards (e.g, ISO13485, IEC 60601 and ISO 14971)
- Advanced knowledge of medical device regulations (e.g. MDR 745/2017, 21CFR820.30, NMPA-Regulation)
- Experience with product or design and development or quality engineering of sterile disposables utilizing various plastic processes such as injection molding and extruding
- Deep understanding of Design Controls and solid engineering expertise that enables them to guide engineering teams
- Experienced with development of design input and traceability through verification and validation V&V activities
- Excellent presentation and communication skills, high engagement on achieving targets and ability to communicate technical information to non-technical audiences
- Willingness to travel national and international
- Fluent in written and spoken English and German
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
What we stand for
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.