Title:  QA Engineer

Job Summary

This role is a Fixed Term- Maternity Cover

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

Education

• B.Sc. in Science or Engineering required

Work Experience

• Minimum 2 years of experience in Medical Device / Pharma industry required
• Experience with Medical Device Design & Development, Verification Activities, Risk Management, Product Transfer, DHF Activities preferred
• Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971 preferred

Preferred Knowledge, 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

Travel Requirements

Physical Requirements

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
• Maintain the ability to work well with others in a variety of situations
• Maintain high attention to detail, accuracy, and overall quality of work
• Be able to multi-task, work under time constraints, problem solve, and prioritize