Overview
Skills
Job Details
Job: QMS (Quality) Program Lead 3-6 month Contract to hire Location: Andover, MA (Onsite, Full-Time) Onsite 5 days Andover
About the Role
we are seeking a hands-on Quality Project Lead to lead the technical and operational aspects of this effort. This is an individual contributor role with a strong focus on business systems analysis (BSA), process definition, and software testing not a traditional project manager position.
The ideal candidate will bring a supply chain and manufacturing background, deep experience in medical device and regulatory environments, and the ability to bridge IT and business operations. This role will be instrumental in defining and validating processes, gathering requirements, and supporting system testing.
Key Responsibilities
Lead the kickoff and execution of the QMS transformation project.
Define and document process requirements in collaboration with Quality, Engineering, Supply Chain, and IT teams.
Perform software testing and QA validation (non-regulatory) to ensure system functionality and alignment with business needs.
Act as a technical SME on QMS systems, supporting configuration, testing, and implementation.
Collaborate with IT to ensure system capabilities meet operational and compliance requirements.
Support SEO, manufacturing, and engineering teams in transitioning to new digital quality workflows.
Drive hands-on execution of testing, validation, and process mapping activities.
Provide input into future PMO structure and governance as the quality function matures.
Required Qualifications
Strong experience in Quality Systems, Supply Chain, and Manufacturing within medical device and regulated environments.
Proven ability to lead technical programs and define business processes.
Experience with software testing, QA validation, and requirements documentation.
Understanding of QMS platforms and their integration with IT systems.
Ability to work independently and drive initiatives as an individual contributor.
Strong communication and stakeholder engagement skills.
Program management experience with a technical edge; ability to balance IT and business needs.
Nice to Have
Experience in building or contributing to a PMO.
Familiarity with SEO or digital quality tools.
Change management exposure or training.