Role: Senior Software Quality Assurance Engineer

Work location: Andover, MA

job id- CGEMJP(phone number removed)



Job Description:

As a Senior Software Quality Assurance Lead – IDE & PMA (SDLC Governance) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end to end software quality across the development lifecycle for systems supporting IDE clinical investigations and PMA submissions. Working onsite and reporting to the Head of Quality, you will govern software quality practices, ensure compliance with FDA regulations, and proactively identify gaps or inconsistencies in existing SOPs.



Key Responsibilities

In this role you will play a key role in:

• Owning software quality governance across the SDLC, ensuring readiness from requirements through V&V and release for IDE and PMA

• Reviewing and challenging existing SOPs and quality pr...