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Career

Are you an experienced QA/RA professional?

Who are we? We are a Quality and Regulatory consulting company managed by Asaf Azulay.

Where? Our office is in Petah Tikvah, but we work all over the central part of Israel.

What do we do? We work with clients in the Medical Device field to build and implement their quality management system, as well as prepare regulatory strategy plans and files.

 

Quality Engineer   job #115 

Job Description:  Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. 

Requirements:

  • Visit suppliers and follow up on identified corrective actions and/or other improvements for CM and suppliers. 
  • Performance monitoring of Quality goals: Follow-up of production trends, process and final testing at CM and at suppliers. Create Quality Metrics presentation slides for Quality Management Review.
  • Use root cause analysis tool and/or work with supplier using root cause analysis tool to investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all types of production processes.   Create an action plan of corrective action and complete/coordinate work and reports in order to resolve the issue. 
  • Develop training and documentation materials for production (e.g., work instructions, verification and validation reports) to enable the seamless knowledge transfer of project and manufacturing processes
  • Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
  • Assist with performing internal and supplier Quality System, process and product audits

 Qualifications:

  • Motivated Junior Engineer that has a desire to be an Engineering in the Medical Device Field.
  • Basic understanding of statistical techniques (i.e. Data analysis avg., std. dev, process capability, etc.)
  • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Solid problem-solving, organizational, analytical and critical thinking skills
  • Experience in methods to understand processes and equipment used in assigned work
  • Knowledge of ISO 13485 and FDA requirements processes
  • Familiar with the following Quality tools: Risk Analysis (FMEA), Cause & Effect Analysis, Good Documentation Practices.   
  • Familiar with Validation
  • Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
  • Good computer skills in usage of MS Office Suite
  • Good documentation, English/Hebrew communication skills and interpersonal

 Please send your CV to ayelet@li-med.com

Only suitable candidates will be contacted.

Validation Engineer  job #116
  • Design and implementation of validation processes
  • Extracting samples and performing validation tests
  • Writing of validation protocols
  • Ability to cooperate with other interfaces in the company : R & D, manufacturing, laboratories, registration, subcontractors, suppliers and more.
Skills: Requirements
  • B.Sc. in Chemistry / Chemical Engineering / Biotechnology Engineering/ Validation Engineering2-3 years previous experience in a medical device company - a must
  • High verbal and written skills both in Hebrew and in English
  • Ability to work independently, teamwork and work with diverse interfaces

 Please send your CV to ayelet@li-med.com

 Only suitable candidates will be contacted.

 

Quality expert requirements job #117

  • B.A. in Mechanical Engineering/ Quality Engineering/ Biotechnology/ Life Sciences
  • 2 years of experience with medical device Quality and Regulatory requirements (ISO13485, GMP)
  • Experience in writing and implementing Quality system comply with ISO13485
  • Experience working with R&D and Manufacturing departments
  • Familarity with the Medical Device Directive (MDD) requirements
  • Has participated at least once in a CE quality/regulatory audit
  • Languages: proficient in Hebrew and English (reading, writing and speaking)

 Please send your CV to ayelet@li-med.com

Only suitable candidates will be contacted.

 

 Regulatory affairs expert requirements job #118

  •  B.A. in Mechanical Engineering/ Quality Engineering/ Biotechnology/ Life Sciences
  • 2 years of experience with medical device Quality and Regulatory requirements (ISO13485, GMP)
  • Experience in writing and submitting regulatory documents for the

             European and American regulatory bodies

  • Experience with CE regulatory requirements
  • Has participated at least once in a CE quality/regulatory audit
  • Languages: proficient in Hebrew and English (reading, writing and speaking)

 Please send your CV to ayelet@li-med.com

Only suitable candidates will be contacted.

 

מנהל QC / ביקורת איכות  משרה #119

  • תואר: מהנדס איכות /הנדסאי איכות / הנדסאי מכונות/ מנהל QC
  • הכרחי -  ניסיון בתחום הציוד הרפואי (שנתיים לפחות)  בסביבת 13485ISO במחלקת איכות
  • הכרת הדרישות לעבודה בחדר נקי (ניסיון עבודה בסביבת חדק נקי – חובה)

   אופי העבודה:

  • ניהול שוטף של תחום איכות ייצור ביקורת קבלה / תהליך / ביקורת סופית כולל הגדרת הדרישות לביקורת
  • ידע בקריאת שרטוטים
  • ניסיון בביצוע בדיקות עם כלי מדידה קליבר / מיקרומטר / פיני מדידה
  • סיוע בביצוע וואלידציות לתהליכי ייצור
  • ניהול תהליכי MRB, ואישור חריגות
  • מעקב על תהליכי ניטור חדר נקי ועבודה לפי דרישות GMP
  • יכולת כתיבה של מפרטי בדיקות לביקורת קבלה, תהליך, סופית
  • עבודה מול קבלני משנה, אישור ספקים ובקרת איכות ספקים
  • שפות: עברית ואנגלית ברמה גבוהה (קריאהת כתיבהת דיבור)
  • משרה מלאה

נא לשלוח קו"ח למייל ayelet@li-med.com

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