QA Engineer

QA Engineer

This is a backfill for maternity leave. In this role, you will be responsible to control all Quality functions including the expansion and maintenance of the Quality System, provide support for product and process improvements by collecting, compiling, and analyzing inspection and process date, and ensure the effective use of resources to meet site quality requirements.

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.
• Finding solutions for queries within responsibility limits.
• Assist and provide guidance on any out of specification result, deviation, or excursion that may occur.
• QA representative in equipment development design reviews.
• 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, 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 maintenance activities (dose audit and bioburden), calibration etc

Additional Responsibilities

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.

License and Certifications

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