QA Engineer

In this fully onsite role, the QA Engineer supports product developments and provides quality oversight to the R&D activities while working within a multi-functional team environment for medical devices.

The QA Engineer will play an active role to ensure the design and development process meets quality standards consistent with internal procedures and acceptance criteria, while meeting all design control and applicable regulatory requirements as well as being involved in QA activities.

Essential Duties and Responsibilities
QA focal point for R&D projects in design and development processes.
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards
Responsible for final approval of R&D and lab documentation- reviewing and approving technical and DHF documentation and lab work instructions/test method.
Responsible for approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, protocols, reports, product design transfer)
Responsible for approval of product design changes and process changes (ECO)
Finding solutions for queries within responsibility limits
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in product development design reviews
Work cross-functionally with individuals and project or extended teams to provide guidance and ensure success of projects
Attend program meetings as required as part of extended program teams
Responsible for approval of labelling