Senior Design Quality Assurance Engineer

4 weeks ago


Lawrence, Massachusetts, United States Fresenius Medical Care North America Full time
Purpose and Scope

As a Senior Design Quality Assurance Engineer at Fresenius Medical Care North America, you will participate in the New Product Development (NPI) and design changes, Design History File (DHF) and Device Master Record (DMR) reviews meetings and fully understand the design control process and Quality Engineering. You will utilize your technical training and compliance experience to ensure that company design control projects comply with internal design control procedures in accordance with FDA and ISO requirements.

Key Responsibilities

Participate in NPI and design changes, DHF and DMR reviews meetings
Utilize technical training and compliance experience to ensure design control projects comply with internal procedures and FDA/ISO requirements
Act as a subject matter expert on design control process and Quality Engineering
Provide guidance to engineering staff and other personnel on design control requirements
Review and approve design control related Change Notices (CNs) within the documentation system

Requirements

Bachelor's Degree in related engineering or scientific discipline required; Advanced Degree desirable
5 – 8 years' related experience; Master's degree with >3 years' related experience; PhD without experience; or equivalent directly related work experience
Working knowledge of Software development lifecycle, IEC 62304, Risk management (ISO 14971), Sofware as a Service/SaMD product development, IEC Health Software, and Agile Software Development practices
Creative problem solving and ability to work independently on high visibility new product development projects

Additional Responsibilities

As a Senior Design Quality Assurance Engineer, you will also be responsible for creating processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards. You will represent the design quality functions for the review and approval of designated design outputs and assist in the development and maintenance of company procedures for design control, change managements, risk management, process validation and related areas of the quality management system.

Working Conditions

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education

Bachelor's Degree in related engineering or scientific discipline required; Advanced Degree desirable

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