West Pharma Quality Engineer Temp 

Israel, Center District, Raanana 

524158834

Job Summary:

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:

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

Basic Qualifications:

• 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

:

• 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:

• None: No travel required

Physical & Mental Requirements:

Very Heavy/ Heavy/ Medium/ Light/ Sedentary:

List any mental requirements:

1. Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events

2. Maintain the ability to work well with others in a variety of situations

3. Maintain high attention to detail, accuracy, and overall quality of work

4. Be able to multi-task, work under time constraints, problem solve, and prioritize

Delegation/s (Title):

• Sr. Engineer-Team Leader, Design Quality or qualified Design Quality Engineer