For more jobs and additional info about:Mazor Robotics, Ltd., a Medtronic company
סינון משרות
דרושים sap
Quality Systems Manager
לפני 15 דקותהגש/י מועמדותFor more jobs and additional info about:Mazor Robotics, Ltd., a Medtronic company
Mazor Robotics, Ltd., a Medtronic companyIn this exciting role as a Quality Systems Manager you will directly leading the site quality management systems to ensure complaince with applicable regulatory requirements and corporate policies activities at our Ceasarea facility. You will have the opportunity to drive a culture of continuous improvement by deploying sound quality system processes and tools to achieve quality objectives and ultimately yielding better patient outcomes.
Responsibilities may include the following and other duties may be assigned.
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
• Chairs the CAPA goverrnance board
• Leads the site quality planinig and KPI program.
• Leads the planning and execution of management reviews and resulting actions.
• Supervise QMS specialists team leading CAPA, Training and QMS doc control.
Responsibilities may include the following and other duties may be assigned.
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
• Chairs the CAPA goverrnance board
• Leads the site quality planinig and KPI program.
• Leads the planning and execution of management reviews and resulting actions.
• Supervise QMS specialists team leading CAPA, Training and QMS doc control.
Job Requirements:• B.S. Degree in a related scientific or engineering discipline and minimum of 10 Years of Quality Assurance experience in Medical device companies or other highly regulated industries
• Minimum of 3 years proven managerial experience Experience in quality management roles.
• Extensive understanding and knowledge of applicable regulations and standards (Such as FDA 21 CFR QSR 820, ISO 13485, ISO 14971, EUMDR, MDSAP. Etc.)
• Fluent in English and Hebrew
Nice to Have
• Advance degree in a related scientific or engineering discipline
• Experience in working in global corporate environment
• Certified Quality Engineer (CQE) or other similar Quality certifications
• Minimum of 3 years proven managerial experience Experience in quality management roles.
• Extensive understanding and knowledge of applicable regulations and standards (Such as FDA 21 CFR QSR 820, ISO 13485, ISO 14971, EUMDR, MDSAP. Etc.)
• Fluent in English and Hebrew
Nice to Have
• Advance degree in a related scientific or engineering discipline
• Experience in working in global corporate environment
• Certified Quality Engineer (CQE) or other similar Quality certifications
Required Experience:7 שנים ומעלה
Locations:מרכז, שרון, צפון
Location:קיסריה
Sub Categories:אבטחת איכות
Job Scopes:משרה מלאה
For more jobs and additional info about:Mazor Robotics, Ltd., a Medtronic company
Senior Quality Systems Specialist - CAPA
לפני 15 דקותהגש/י מועמדותFor more jobs and additional info about:Mazor Robotics, Ltd., a Medtronic company
Mazor Robotics, Ltd., a Medtronic companyIn this exciting role as a Sr. QMS Specialist - CAPA you will provide technical support to all areas of Mazor Robotics by facilitating the Corrective and Preventive Action system (CAPA) program, including providing input, organizing and analyzing the data and managing actions.
Responsibilities may include the following and other duties may be assigned.
• Manage CAPA activities and documentation to assure compliance with CAPA policies and procedures, FDA regulations, ISO 13485, and Medical Device Requirements through the review of CAPA records at critical phases.
• Lead the cross functional teams to provide investigations of product quality issues and process deviations.
• Provide guidance and expertise to ensure detailed CAPA Root Cause Analysis. Apply problem solving techniques to problems of various scope and complexity.
• Support the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training programs.
• Generate CAPA metrics.
• Recommend and implement product quality and process improvements. Provide written reports and supporting documentation for investigations.
Responsibilities may include the following and other duties may be assigned.
• Manage CAPA activities and documentation to assure compliance with CAPA policies and procedures, FDA regulations, ISO 13485, and Medical Device Requirements through the review of CAPA records at critical phases.
• Lead the cross functional teams to provide investigations of product quality issues and process deviations.
• Provide guidance and expertise to ensure detailed CAPA Root Cause Analysis. Apply problem solving techniques to problems of various scope and complexity.
• Support the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training programs.
• Generate CAPA metrics.
• Recommend and implement product quality and process improvements. Provide written reports and supporting documentation for investigations.
Job Requirements:• B.S. Degree in a related scientific or engineering discipline and minimum of 4+ Years of Quality Assurance experience in Medical device companies or other highly regulated industries, or an advanced degree with a minimum of 2 year relevant experience.
• Extensive understanding and knowledge of applicable regulations and standards (Such as FDA 21 CFR QSR 820, ISO 13485, ISO 14971, EUMDR, MDSAP, Etc)
• Fluent in Hebrew and English is preferred
Nice to Have
• Prevoius experience in leading Corrective and Preventive action.
• Experince with Trackwise
• Certified Quality Engineer (CQE) or other similar Quality certifications
• Extensive understanding and knowledge of applicable regulations and standards (Such as FDA 21 CFR QSR 820, ISO 13485, ISO 14971, EUMDR, MDSAP, Etc)
• Fluent in Hebrew and English is preferred
Nice to Have
• Prevoius experience in leading Corrective and Preventive action.
• Experince with Trackwise
• Certified Quality Engineer (CQE) or other similar Quality certifications
Required Experience:5-6 שנים
Locations:מרכז, שרון, צפון
Location:קיסריה
Sub Categories:אבטחת איכות
Job Scopes:משרה מלאה
For more jobs and additional info about:Mazor Robotics, Ltd., a Medtronic companyQuality Assurance Manager (Medical Device)
לפני 3 שעותשלח קורות חייםהוסף לסל
MedasenseWe 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.
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)
5 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
5 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
For more jobs and additional info about:Medasense
רוקח/ת בקרה קונסיגנציה - אגף רכש ובקרה
לפני 5 שעותשלח קורות חייםהוסף לסל
לאומית שירותי בריאותניהול, פיקוח ובקרה על התקשרויות עם בתי חולים ומכונים בכל הנוגע לטיפול התרופתי
מענה יומיומי לפניות ספקים (בתי מרקחת פנימיים וחיצוניים ובתי חולים)
תפקיד שטח הכולל נסיעות לבקרות תקופתיות בבתי חולים/בתי מרקחת/מכונים.
אספקה סדירה של תרופות ליחידות בית החולים, לרבות ניהול מלאי וביצוע הזמנות סחורה
קליטת קבצים ממוחשבים ובקרת שימושים.
ביצוע בקרה באמצעות מעבר על תיקי מבוטחים.
סיוע בניהול פרויקטים מחשוביים ותהליכיים בתחום.
ניתוח נתונים והצגת מסקנות
מענה יומיומי לפניות ספקים (בתי מרקחת פנימיים וחיצוניים ובתי חולים)
תפקיד שטח הכולל נסיעות לבקרות תקופתיות בבתי חולים/בתי מרקחת/מכונים.
אספקה סדירה של תרופות ליחידות בית החולים, לרבות ניהול מלאי וביצוע הזמנות סחורה
קליטת קבצים ממוחשבים ובקרת שימושים.
ביצוע בקרה באמצעות מעבר על תיקי מבוטחים.
סיוע בניהול פרויקטים מחשוביים ותהליכיים בתחום.
ניתוח נתונים והצגת מסקנות
דרישות התפקיד:תואר ראשון ברוקחות ורישיון רוקח - תנאי סף
ניסיון של 5 שנים כרוקח/ת דלפק(בקופות חולים/בתי חולים/שוק פרטי) - תנאי סף
ידע באקסל ויכולת ניתוח אנליטית - חובה
רישיון נהיגה בתוקף + רכב שישמש בבקרות - חובה
עברית ברמת שפת אם - חובה
ידיעת החוקים, התקנות, הכללים והנהלים המתייחסים לתכשירים רפואיים - חובה
היכרות עם מערכת הבריאות בדגש על הקשר בין בתי חולים וקופות חולים - יתרון
ידע בעבודה מול as400 – יתרון
ידע בעבודה ב-sap – יתרון
ניסיון של 5 שנים כרוקח/ת דלפק(בקופות חולים/בתי חולים/שוק פרטי) - תנאי סף
ידע באקסל ויכולת ניתוח אנליטית - חובה
רישיון נהיגה בתוקף + רכב שישמש בבקרות - חובה
עברית ברמת שפת אם - חובה
ידיעת החוקים, התקנות, הכללים והנהלים המתייחסים לתכשירים רפואיים - חובה
היכרות עם מערכת הבריאות בדגש על הקשר בין בתי חולים וקופות חולים - יתרון
ידע בעבודה מול as400 – יתרון
ידע בעבודה ב-sap – יתרון
שנות נסיון:1-2 שנים
איזורים:מרכז, שרון, צפון
מיקום המשרה:תל אביב
תחומים:רוקח, מנהל רפואי, רפואה - ניהול
היקף המשרה:משרה חלקית
משרות נוספות וכל מה שצריך לדעת על:לאומית שירותי בריאות
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