Title:  QA Engineer

Job Summary

In this role, you will be supporting Engineering department as well as being involved in QA activities.

Location- Shlomi.

Essential Duties and Responsibilities

• QA focal point for engineering projects.
• Provide guidance on documentation structures and formats to ensure compliance to procedures, relevant regulations, and standards.
• Participate in equipment and process validation (IQ, OQ, PQ) on site.
• Responsible for approval of engineering documentation - reviewing and approving technical, mold, test method, equipment and process validation (IQ, OQ, PQ) documentation.
• Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
• QA representative in equipment development design reviews and in in equipment and process validation reviews.
• Responsible for calibration of inspection equipment, including the coordination of calibration with the calibration lab, follow up, approval of the calibration records and handling any calibration deviations. 
• 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, URS, design verification & validation activities, dFMEA, pFMEA, FMEA risk documents, test methods, OOSs, protocols, reports, product design transfer)
• Support other QA dept activities, routine sterility validation (dose audit and bioburden) maintenance activities,etc

Education

B.Sc. in Science or Engineering

Work Experience

Minimum 2 years of experience in Medical Device Quality & Product Development Lifecycle

• Experience in Medical Device / Pharma industry
• Experience with Medical Device Design & Development, Verification Activities, Risk Management, Product Transfer, DHF Activities
• Experience in Equipment Validation, Process Validation, Change Control Process
• Strong working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971

Preferred Knowledge, Skills and Abilities

• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.
• Technical skills
• 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

• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve and prioritize.
• Self-motivated with the ability to make independent and sound judgments.
• Read and interpret data, information, and documents
• Learn and apply new information or skills