QA Engineer

1 week ago

Raanana, Central District, Israel West Pharmaceutical Services Full time ₪42,000 - ₪84,000 per year
Job Summary

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
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

  • QA Engineer

    6 hours ago

    Raanana, Central District, Israel Truvid Full time ₪60,000 - ₪120,000 per year

    We are seeking a Manual QA Engineer to join our QA team.You'll develop comprehensive test plans for new features across multiple environments and manage testing cycles for both our customer-facing console and internal admin tools throughout the deployment process.Working alongside cross-functional teams, you'll play a key role in maintaining rigorous quality...

  • Manual QA Engineer

    6 hours ago

    Raanana, Central District, Israel Rail Vision Full time ₪60,000 - ₪80,000 per year

    Rail Vision is a multidisciplinary startup headquartered in Ra'anana. We utilize the latest Artificial Intelligence and Electro Optics technologies and develop lifesaving, vision systems for the global railway market.We're looking for a QA Engineer to join our teamWhat you will do:You will have the opportunity to characterize and lead our testing strategy...

  • Manual QA Engineer

    6 hours ago

    Raanana, Central District, Israel Rail Vision Full time ₪45,000 - ₪75,000 per year

    Rail Vision is a multidisciplinary startup headquartered in Ra'anana. We utilize the latest Artificial Intelligence and Electro Optics technologies and develop lifesaving, vision systems for the global railway market.We're looking for a QA Engineer to join our teamWhat you will do:You will have the opportunity to characterize and lead our testing strategy...

  • QA Network Engineer

    6 hours ago

    Raanana, Central District, Israel DRIVENETS Full time ₪120,000 - ₪180,000 per year

    Location: Ra'anana#HybridDriveNets is a leader in high-scale disaggregated networking solutions. Founded in 2015, DriveNets modernizes the way service providers, cloud providers and hyperscalers build networks. Supporting the largest network in the world, more than half of AT&T's backbone traffic is running on DriveNets' Network Cloud open disaggregated...

  • System QA

    6 hours ago

    Raanana, Central District, Israel D-Fend Solutions Full time ₪40,000 - ₪60,000 per year

    D-Fend Solutions is a successful, fast-growing, startup located in Ra'anana, D-Fend has developed and brought to market an advanced autonomous counter-drone system which automatically detects, locates and mitigates rogue drones by TAKING CONTROL over the communication links of hostile drones, and land them safely in a designated zone.Our ideal candidate is...

  • System QA

    6 hours ago

    Raanana, Central District, Israel D-Fend Solutions Full time ₪45,000 - ₪75,000 per year

    D-Fend Solutions is a successful, fast-growing, startup located in Ra'anana, D-Fend has developed and brought to market an advanced autonomous counter-drone system which automatically detects, locates and mitigates rogue drones by TAKING CONTROL over the communication links of hostile drones, and land them safely in a designated zone.Our ideal candidate is a...

  • DevTest Engineer

    6 hours ago

    Raanana, Central District, Israel Drivenets Full time ₪120,000 - ₪360,000 per year

    Hybrid- RaananaAbout DRIVENETS:DRIVENETS is at the forefront of transforming next-generation networks with our innovative Network solution. We were founded to tackle the "data explosion challenge"—a key issue for service providers, content providers, public , and enterprise clients worldwide. Our advanced technology reshapes network economics by leveraging...

  • SIT Network Engineer

    6 hours ago

    Raanana, Central District, Israel DRIVENETS Full time ₪120,000 - ₪180,000 per year

    DRIVENETS is driving and leading the next-generation networks with our Network Cloud solution.DRIVENETS was founded to solve the "data explosion challenge" - one of the biggest challenges for service providers, content providers, public cloud, and enterprises.Our cutting-edge technology and Network Cloud solution have created a paradigm shift in the economy...

  • Automation Engineer

    2 weeks ago

    Raanana, Central District, Israel NICE Full time ₪80,000 - ₪120,000 per year

    At NiCE, we don't limit our challenges. We challenge our limits. Always. We're ambitious. We're game changers. And we play to win. We set the highest standards and execute beyond them. And if you're like us, we can offer you the ultimate career opportunity that will light a fire within you.So, what's the role all about?We are seeking an Automation Engineer...

  • Principal DevOps Engineer

    6 hours ago

    Raanana, Central District, Israel Red River Full time ₪120,000 - ₪180,000 per year

    Job Summary:Our team, a vital part of the Telco Verification Pillar, is developing and operating a cutting-edge CI/CD service to empower our Testing Teams with enhanced automation capabilities. As a Principal Software Engineer specializing in Test Automation, CI/CD, and DevOps, you will be instrumental in ensuring the quality, reliability, and efficiency of...