Design Assurance Engineer - Palazzo Pignano, Italia - Fresenius Medical Care, Global Manufacturing, Quality & Supply

Descrizione

Goal of function:

Assure the quality of design control activities and correctly realizing product development processes;

Maintenance of product compliance.

Main tasks:

Ensure that all design control deliverables comply with applicable regulatory requirements and design controls SOPs;

Prepare together with Project Manager's the design and development documentation for project and for design control activities;

Support Product Center/Project Manager to get part of DHF needed to Medical Device Compliance and Regulatory Affairs to complete Technical Dossier/Registration dossier;

Provide Training on design & development relevant quality requirements;

Provide input to design and development and design changes and take accountability for quality compliance as a member of the cross-functional project team representing Product Center for Design Quality part;

Review and approve all product development and Design Change projects in compliance with Fresenius Quality Management System / SOP requirements by:

Preparation / Review and approval of applicable design control documentation

Design Review, Phase Exit Review and Milestone approval

Preparation of applicable document and sample review of design control documentation during project execution

Quality Approver for Design and Development related NC/CAPA

Requirements

Required educational background:

Technical/Engineering / Scientific background (degree)

Required professional experience:

Experience of minimum 2-3 years in Regulatory Affair in pharmaceutical/medical field

Technical knowledge:

Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 745/2017, MDSAP etc.)

Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250, etc.)

Knowledge of internal and external processes and structures and of the corporate Quality Management requirements

Knowledge of CAPA methodology

Knowledge in statistical methods

Good knowledge of English is required.

Career with a purposeWe offer an opportunity to create and deliver treatments that save and change lives for the better. We'll support your ongoing development. And you'll be part of a dedicated team of people who inspire each other to create the best possible healthcare outcomes each and every day. Inclusion and diversityJoining Fresenius Medical Care means becoming part of a team that values diversity. We embrace the wealth of different backgrounds, cultures, experiences and opinions that make up our workforce and strive to create an inclusive atmosphere in which all our employees feel valued. StabilityDeveloping innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth . This position provides our employees with the stability and security they need to help improve the lives of our patients. Learning and developmentWe offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7. Local benefitsOur employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere. Work-life balanceWe want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more.