In this role, you will be supporting the Engineering department as well as being involved in QA activities.
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 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.
B.Sc. in Science or Engineering.
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.
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.