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