לוח משרות דרושים מהנדס בדיקות ברעננה

In this role, you will be supporting Engineering and R&D departments as well as being involved in QA activities.

The QA engineer position is temporary for 2 years (project support).

Essential Duties and Responsibilities:



QA focal point for engineering 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 engineering documentation- reviewing and approving technical, mold and process validation documentation (IQ, OQ, PQ).
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in equipment and process validation 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.
Provide support, when necessary, with review and approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, OOSs, protocols, reports, product design transfer)
Support other QA dept activities- second approval of batch release/graphics, routine sterility validation maintenance activities (dose audit and bioburden), calibration etc.
Responsible for final approval of engineering documentation- reviewing and approving test method validation
Competencies/Authorities

Approve equipment qualification documents (URS, pFMEA risk documents, IQ, OQ, PQ)
Approve validation protocols and reports.
Support all engineering activities.

n this role, the QA Engineer supports products development 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 documentation- reviewing and approving technical and DHF documentation.
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
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