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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 12 שעות
שלח קורות חייםהוסף לסל
Medasense is looking for a Quality Assurance manager that will hold the key competence within quality oversight of Medasense products.
The QA Manager will be responsible for the quality assurance of all device activities and will work closely with all departments to ensure that all external and internal requirements are met before our product reaches our customers.
The ideal candidate is a reliable and competent professional whose approval will be necessary for the continuation of a business life cycle. An addition to exceptional leadership and analytical skills, you must have a “roll-up your sleeves” attitude.
Duties and Responsibilities
• Responsible to perform and monitor of all routine QA activities (controlled documents, CAPA, complaints, trainings, suppliers control etc.) and ensure compliance to regulatory and procedural requirements.
• Initiate and verify implementation and effectiveness of corrective actions derived from internal and external audits
• Responsible for audit preparation and participation in internal and external audits
• Responsible for leading quality initiatives with operations to improve manufacturing processes and product quality.
• Develop and submit Quarterly Management review reports.
• Compilation and maintenance of Technical Files / Design Dossiers.
• Customer complaints handling and vigilance reporting
Job Requirements:• BSc in engineering or Certified Quality Engineer (CQE)
• At least 5 years of experience as a QA Manager at a Medical Device company
• Familiar with AQL sampling process
• Familiar with ISO13485, ISO 1345:2016, MDSAP, MDD and FDA QSR 820.
• Experience in participation in external and internal audits
• Certified auditor – an advantage
• Familiar with Agile- an advantage
• Excellent Hebrew and English.
Required Experience:5-6 שנים
Locations:מרכז
Sub Categories:אבטחת איכות, רגולציה
Job Scopes:משרה מלאה

(Production QA Engineer (Medical Device

לפני 12 שעות
שלח קורות חייםהוסף לסל
Medasense is looking for a reliable Production Quality Assurance Engineer to ensure that all external requirements are met before our product reaches our customers. You will be responsible for inspecting procedures and outputs and identifying mistakes or non-conformity issues.
Duties and Responsibilities
• Oversee all production quality processes, including oversight of contract manufacturers.
• Partner with engineering and operations teams in NPI processes and ongoing quality improvement initiatives
• Analyze and present supplier quality metrics
• Perform suppliers' certification and annual audits according to an annual plan.
• Support company QMS activities eg CAPA, customer complaints, MRB, audits as required.
• Executed risk analyses with control plan (PFMEA)
• Control ECO process including managing and reviewing ECO
• Other tasks related to Production and QC department, as deemed necessary.
Job Requirements:• BSc in engineering or Certified Quality Engineer (CQE)
• At least 3 years' experience in suppliers' and production quality management in a medical device company.
• Familiar with ISO13485:2016, FDA QSR 820 standards
• Experience in participation in external and internal audits – an advantage
• Certified auditor – an advantage
Essential Attributes:
• Fluency in English & Hebrew – spoken and written
• 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:3-4 שנים
Locations:מרכז
Sub Categories:אבטחת איכות
Job Scopes:משרה מלאה
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