In this role, the selected candidate will assist developers in reproducing problems and getting them resolved; participates in design activity with other programmers on technical aspects relating to testing, including functional specifications, design parameters, feature enhancements, and alternative solutions.
The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures.
In this role, the selected candidate will lead and provide guidance with Product Development Manufacturing Engineering in development of test, develop production acceptance criteria, test methods, and process validation protocols.
The Senior Quality Assurance Analyst will co-manage the quality assurance (QA) oversight of internal departments and third-party vendors and ensure compliance with the Federal Transit Administration (FTA) Quality Management System (QMS) Guidelines.
In this role, the selected candidate will collaborate with other members of the engagement team to plan the engagement and develop work program timelines, risk assessments, and other planning documents.