Principal Design Quality Engineer

Job description

PURPOSE AND SCOPE: 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. Utilize 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. PRINCIPAL DUTIES AND RESPONSIBILITIES: Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. - A seasoned, experienced professional with a full understanding of design control process; resolves a wide range of issues in creative ways. - Responsible for assuring projects meet customer expectations, and regulatory requirements. - Act as a subject matter expert on design control process and Quality Engineering. The Quality Engineering subjects are Risk Management, Test Method Validation (TMV), Statistics, Reliability Engineering, Process Validation (PV). - Successfully address complex engineering issues where analysis of situations or data requires an in-depth eva...