In this role, you will be supporting Engineering and R&D departments as well as being involved in QA activities.
The QA engineer position is temporary for 2 years (project support).
Essential Duties and Responsibilities:
QA focal point for engineering 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 engineering documentation- reviewing and approving technical, mold and process validation documentation (IQ, OQ, PQ).
Assist and provide guidance on any out of specification result, deviation, or excursion that may occur
QA representative in equipment and process validation 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.
Provide support, when necessary, with review and approval of product development DHF documentation (DDP, PRD, TMX, design verification & validation activities, dFMEA risk documents, test methods, OOSs, protocols, reports, product design transfer)
Support other QA dept activities- second approval of batch release/graphics, routine sterility validation maintenance activities (dose audit and bioburden), calibration etc.
Responsible for final approval of engineering documentation- reviewing and approving test method validation
Competencies/Authorities
Approve equipment qualification documents (URS, pFMEA risk documents, IQ, OQ, PQ)
Approve validation protocols and reports.
Support all engineering activities.
Requirements: Education: B.Sc. in Science or Engineering or any other relevant education
Experience in Medical Device / Pharma industry minimum 2 years of experience
Experience with Medical Device Design & Development, Verification Activities, Risk Management, Product Transfer, DHF Activities advantage
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, languages, 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 companys safety policy at all times
Able to comply with the companys 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.
This position is open to all candidates.
