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דרושים Medasense

Medasense Biometrics is a medical technology company in the field of pain. Medasense has developed a proprietary technology platform, which identify and grades the individual physiological response to pain- spearheading pain management towards personalized care. Medasense’s technology is available in Europe, Canada and Israel – it enables clinicians to optimize the pain treatment and by that, minimize adverse events, improve clinical outcomes and reduce costs.

Quality Assurance Manager (Medical Device)

לפני 7 שעות
שלח קורות חייםהוסף לסל
We are looking for a talented and passionate Quality Assurance manager to lead quality at both the product and system level for an innovative patient monitoring device combining state of the art algorithms, software, electronics and hardware. The QA Manager will be responsible for the building and execution of work processes that ensure that all external and internal requirements are met before and after our product reaches our customers. In addition to exceptional leadership, communication and analytical skills, you must have a “roll-up your sleeves” attitude and a deep understanding of global regulatory requirements in the medical device world.
Duties and Responsibilities
Oversight and performance of all routine QA activities ( CAPA, complaint handling & vigilance, document control, risk management, failure investigations, purchasing controls etc.) ensuring compliance with regulatory and company procedure requirements.
audit preparation and participation in internal and external audits
leading quality initiatives with operations to improve manufacturing processes and product quality.
preparation of mgmt. reviews of quality system
Compilation and maintenance of Technical Files / Design History Files.
Overseeing design controls from user needs to serial production
Working hours: Full-time job. The position requires travelling from time to time to suppliers in the north of Israel and abroad.
Report to: VP Clinical, Regulatory and Quality.
Interfaces with: Operations, Hardware, SW, marketing Clinical & Regulation.
Job Requirements:BSc in engineering or Certified Quality Engineer (CQE)
3 years of experience as a QA Manager at a Medical Device company
Familiar with quality system standards ISO 13485,, MDSAP, MDD , 21CFR 820, ISO 14971. Knowledge of MDR an advantage
Familiar with device standards such as IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993 and usability standards
Experience in leading external and internal audits
Certified auditor – an advantage
Familiar with Agile or other document control systems- an advantage
Excellent Hebrew and English.
Strong attention to detail and accuracy
Well organized with an understanding of priorities and changing demands
Highly motivated, team player, passionate with independent learning and working abilities
Required Experience:5-6 שנים
Locations:רמת גן / גבעתיים
Location:רמת גן
Sub Categories:אבטחת איכות, רגולציה
Job Scopes:משרה מלאה
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