In 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
Requirements: Education: B.Sc. in Science or Engineering
Minimum 2 years of experience in Medical Device / Pharma industry Quality
Experience with Medical Device Design & Development, Verification Activities, Risk Management, Product Transfer, DHF Activities - Advantage
Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971- Advantage
Preferred Knowledge, languages, Skills and Abilities:
Ability to work under pressure
Good interpersonal skills
Technical skills
Creativity
Quick learner
Orderly and organized person
The ability to prioritize based on importance
Written and verbal expression skills: Hebrew- Excellent, English- Excellent
Relevant work history and/or experience may be considered in lieu of degree
This position is open to all candidates.
