Design Assurance Speicialist - Fresenius Medical Care Holdings, Inc.

Position in Ogden, Utah.

PRINCIPAL DUTIES AND RESPONSIBILITIES:  

• 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 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

• Act as Quality Approver for Design and Development related NC/CAPA
• Create and monitor compliance metrics of design controls in development and change management activities.
• Audit support of design and development sessions
• Providing management quality review inputs for Design and development
• Support Product Center in writing MDR Technical Documentation and related documentation.

EXPERIENCE AND REQUIRED SKILLS:

• Degree in Technical/Engineering and/or Scientific background
• Minimum 2 years in Regulatory Affairs or similar in pharmaceutical/medical field
• Strong relationship building with international colleagues and superiors.
• High engagement on achieving the targets and the objectives of the position, proactive and solution-oriented approach towards problems, ability to work cross functional with all levels of employees.
• Organizational capacity and analytical ability
• Independent working structure
• Autonomy in decision making.
• 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 CFR, etc.)
• Knowledge of internal and external processes and structures and of the corporate Quality Management requirements
• Knowledge of CAPA methodology
• Knowledge in statistical methods
• Support Regulatory Affairs 
• Capability to relate to all corporate functions (at corporate level)
• Interface to keep up to date the technical documentation relevant for regulatory purposes (e.g. usability report, interface verification test report, biocompatibility, labelling etc.)

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.