QA Engineer
6 days ago
In this role, you will be supporting Engineering department as well as being involved in QA activities.
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 ExperienceMinimum 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.
Travel Requirements
10%: Up to 26 business days per year Physical Requirements
Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects. 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
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