Job Description
Job Purpose
The Sr. Quality Engineer will be a key member of the QA organization of a growing medical device company developing and manufacturing software as medical devices. The position will own, manage, or support key areas of Quality Management System (QMS), including but not limited to new product introduction, Design Control, change management, CAPA, complaint handling, suppliers, and training. This role will also interface with cross-functional teams and external partners.
Responsibilities
The Sr. Quality Engineer will be a key member of the QA organization of a growing medical device company developing and manufacturing software as medical devices. The position will own, manage, or support key areas of Quality Management System (QMS), including but not limited to new product introduction, Design Control, change management, CAPA, complaint handling, suppliers, and training. This role will also interface with cross-functional teams and external partners.
Responsibilities
- Manages and supports Controlled Documents on Welldoc's electronic QMS (eQMS) and Learning Management System (LMS). This means you'll be responsible for managing these digital platforms that help us maintain high standards in how we control processes, documents, operate, and how we train our teams to remain compliant with SaMD regulations.
- Play the role of a Quality Lead on product development core teams to advocate QM...
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