New

Design Quality Engineer

Ampcus, Inc
United States, Massachusetts, Walpole
Nov 26, 2024
Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team. Job Title: Design Quality Engineer Location(s): Walpole, MA Position Description: Specific Requirements: The Design Quality Engineer will participate in the governance, and execution of the Quality Management sub-system element of Design Change. Specifically, the person will be required to interact and collaborate with cross functional teams to promote and drive Quality Systems compliance regarding product design and development activities. Additionally, this role will lead specific quality improvement projects as required to support QT and other business initiatives including, but not limited to audits (internal / external), supplier quality, CAPA, and training. Major Job Responsibilities: Participate as a core team member on various design changes. Provide assistance to the engineering partners in the development of design verification and validation testing requirements including protocol development, test methods, acceptance criteria, and statistical plans / techniques; Support the development, monitoring and reporting of Quality Systems key performance indicators (KPIs), which will include assisting in the development of Quality Goals & Objectives across POC. Support internal and external audit needs while serving as the subject matter expert for Design Quality Assurance. Required Knowledge/Skills, Education, and Experience: 2-5 years of experience in a Quality Engineering or similar role within an FDA regulated industry preferably medical device and diagnostics that includes experience with CAPA and auditing processes. Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.