דרושים » אבטחת איכות QA » Quality Assurance Compliance Specialist

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לפני 18 שעות
Location: Tel Aviv-Yafo
Job Type: Full Time
a fast-growing medical technology company transforming the fields of hematology and cell morphology analysis. As a team, we work to enable faster, earlier detection and diagnosis of blood-related diseases, so patients can start treatment sooner and have better outcomes. We are collaborative and global and every individual at is part of a life-saving mission.
About the job
We are looking for a Quality Assurance Compliance Specialist to join our compliance and RA team, which plays a central role in both pre-market and post-market activities. The team is responsible for regulatory activities, quality management system, and ensuring compliance with applicable standards, including those related to privacy.

The Quality Assurance Compliance Specialist will play an important role in the companys regulatory, quality and compliance activities, such as ensuring compliance with relevant quality standards (including ISO 13485:2016, 21 CFR 820, MDSAP and IVDR); supporting internal audits, corrective efforts and different quality projects; and defining quality procedures, protocols and tools.

What youll be doing
Provide ongoing support for the companys quality management activities, including SDLC, PMS, product investigation, operations, training management, supplier management, and document control
Maintain the companys quality management system (QMS)
Evaluate and address quality assessment related to customer complaints
Prepare and maintain technical documentation in compliance with standards such as ISO 13485, 21 CFR 820, and IVDR
Collaborate with cross-functional teams, including R&D, product development, and technical support on quality-related activities
Perform privacy-related tasks, such as evaluating suppliers for privacy compliance and reviewing data processing agreements (DPAs)
Analyze post-market surveillance data to support company initiatives
Prepare teams for internal and external audits
Requirements:
Bachelor's degree in industrial engineering, biotechnology engineering, life science/exact science, or law
At least 5 years of experience working with the QMS of a medical device company, including development, implementation, or compliance with standards such as ISO 13485 and FDA regulations
Understanding of QA processes and methodologies (ISO 13485:2016, 21 CFR 820 or similar)
Understanding of privacy requirements such as HIPAA, GDPR and ISO27799
Ability to collaborate effectively with cross-functional teams to achieve quality objectives
A motivated, collaborative, and proactive approach to work
Team orientation
Excellent communication skills (both written and verbal)
Strong attention to detail
Ability to lead and implement processes
English proficiency
This position is open to all candidates.
 
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המימד השלישי
Job Type: Full Time
A Medical device company,Innovative and successful, in Netanya area is looking for an Experienced Operations Quality Assurance Specialist to join the QA Operations group and support the variety of activities related to QA Operations, such as:

Lead QA Operations activities with regards to verifications/validations for an FDA reviewed complex, multidisciplinary, active investigational device.
Lead and perform the Engineering Change Order (ECO) process from risk analysis through protocol approval.
Verification, execution, and analysis of reports until FDA-ready.
Provide guidance to the R D and Engineering teams on IQ/OQ/PV activities.
Requirements:
B.A. or B.S. degree in a technical discipline, such as Engineering or Science.
3-5 years of relevant experience in the medical device industry.
Previous experience with medical device verification/validations, ECOs, medical device statistics
Working knowledge of medical device international standards.
Ability to work independently with minimal work direction and in a cross-functional team environment.
Fluent in English with excellent writing skills, effective written and verbal communication skills.
Excellent computer skills, including a working knowledge of Microsoft Office applications.
Strong time management abilities to ensure timely task completion.
Detail-oriented
This position is open to all candidates.
 
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הגשת מועמדות
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8156039
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חברה חסויה
Job Type: Full Time and Hybrid work
o Manage SW QA and version approval process
o Manage HW QA approval for Amimon's products
o Handle and manage medical V&V including regulation documents, V&V protocol design and execution.
Requirements:
Electrical/Software Engineering/ Computer Science degree.
o At least 5 years hands-on experience with QA of multi-disciplinary systems (HW, SW, VLSI, Mechanical, Production etc.)
o At least 2 years of leading QA activities
o High organization skills and process control
o High level system understanding.
o Ability of Self learning and independent working.
Team player
This position is open to all candidates.
 
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8149595
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פידליס גרופ מייסודה של חברת ש.ע.ל בע"מ
דרושים בפידליס גרופ מייסודה של חברת ש.ע.ל בע"מ
סוג משרה: משרה מלאה
-אחריות על ניהול משימות צוות: הדרכה, פיקוח ותיאום פעילויות צוות.
-סקירה ואישור של תהליכי אימות בתחומים מרובים (ציוד, תהליכים, ניקיון, שיטות אנליטיות, תשתיות, מערכות, חדרים נקיים, מערכות ממוחשבות).
- ניהול בקרות שינויים ורישומי איכות (סטיות, CAPA).
-כתיבת פרוטוקולים ודוחות לאימות תהליכים וניקיון.
-ביצוע הערכת סיכונים ומתן תמיכה שוטפת לפרויקטים.
-כתיבה ואישור נהלים בהתאם לתקנים הרלוונטיים.
-השתתפות בבדיקות רגולטוריות, ביקורות פנימיות וביקורות ספקים.
-הובלת יוזמות לשיפור איכות.
דרישות:
-תואר ראשון ומעלה באחד מהתחומים הבאים: הנדסת ביוטכנולוגיה, הנדסה כימית, הנדסת פרמצבטיקה, הנדסה ביו-רפואית, כימיה, ביוכימיה, ביוטכנולוגיה, מדעי החיים או רוקחות.
-לפחות 5 שנות ניסיון ניהולי בתחום QA חובה.
-ניסיון בתעשיית התרופות בסביבת GMP - חובה.
-ניסיון רב בכתיבת, סקירה ואישור תהליכי אימות (ציוד, תהליכים, ניקיון, תשתיות) - חובה.
-ניסיון בניהול בקרות שינויים ורישומי איכות - חובה.
-ניסיון בכתיבת SOPs, פרוטוקולים ודוחות.
-ניסיון בהובלה והשתתפות בבדיקות רגולטוריות.
-שליטה באנגלית ברמה גבוהה מאוד- חובה. המשרה מיועדת לנשים ולגברים כאחד.
 
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הגשת מועמדות
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8156542
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תודה על שיתוף הפעולה
מודים לך שלקחת חלק בשיפור התוכן שלנו :)
לפני 20 שעות
חברה חסויה
Location: Tel Aviv-Yafo
Job Type: Full Time
a fast-growing medical technology company transforming the fields of hematology and cell morphology analysis. As a team, we work to enable faster, earlier detection and diagnosis of blood-related diseases, so patients can start treatment sooner and have better outcomes. We are collaborative and global and every individual at is part of a life-saving mission.

About the job
We are looking for a compliance analyst to join our compliance and RA team, which plays a central role in both pre-market and post-market activities. The team is responsible for regulatory activities, quality management system, and ensuring compliance with applicable standards, including those related to privacy.

The analyst will play an important role in the companys regulatory, quality and compliance activities, such as ensuring compliance with relevant quality standards (including ISO 13485:2016, 21 CFR 820, MDSAP and IVDR); supporting internal audits, corrective efforts and different quality projects; and defining quality procedures, protocols and tools.

What youll be doing
Provide ongoing support for the companys quality management activities, including SDLC, PMS, product investigation, operations, training management, supplier management, and document control
Maintain the companys quality management system (QMS)
Evaluate and address quality assessment related to customer complaints
Prepare and maintain technical documentation in compliance with standards such as ISO 13485, 21 CFR 820, and IVDR
Collaborate with cross-functional teams, including R&D, product development, and technical support on quality-related activities
Perform privacy-related tasks, such as evaluating suppliers for privacy compliance and reviewing data processing agreements (DPAs)
Analyze post-market surveillance data to support company initiatives
Prepare teams for internal and external audits
Requirements:
Bachelor's degree in industrial engineering, biotechnology engineering, life science/exact science, or law
At least three years of experience working with the QMS of a medical device company, including development, implementation, or compliance with standards such as ISO 13485 and FDA regulations
Understanding of QA processes and methodologies (ISO 13485:2016, 21 CFR 820 or similar)
Understanding of privacy requirements such as HIPAA, GDPR and ISO27799
Ability to collaborate effectively with cross-functional teams to achieve quality objectives
A motivated, collaborative, and proactive approach to work
Team orientation
Excellent communication skills (both written and verbal)
Strong attention to detail
Ability to lead and implement processes
English proficiency
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
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עדכון קורות החיים לפני שליחה
8170342
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22/04/2025
חברה חסויה
Location: Tel Aviv-Yafo
Job Type: Full Time
We are looking for Quality Manager with a 5 years experience.

This position will be responsible for overseeing the quality within the company, focusing on the development, implementation, and monitoring of quality methodologies and processes.

The role will be hands-on, including internal quality control, supplier audits, development of quality documentation, and management of multidisciplinary processes within the company.

The Quality Manager will work closely with our development & engineers, production, and regulatory teams to ensure compliance with rigorous quality standards.

Key Responsibilities:
Developing Quality Methodology: Develop and implement comprehensive quality methodologies, focusing on multi-disciplinary products (including hardware, electronics, mmechanics and software).
Hands-on Role: Perform independent quality control, design, and manage continuous quality improvement processes.
USO Certification and Quality Control: Ensure compliance with international quality certifications and standards, such as ISO, and specific defense standards (e.g., MIL-STD).
Supplier Audits: Conduct quality audits for suppliers in the hardware and electronics domains, analyze results, and provide recommendations for improvement.
Organizing Proposals and Processes: Define processes for organizing proposals and ensure quality requirements are met during supplier engagement.
Quality Documentation: Create and update technical documents, quality reports, specifications, and standard operating procedures.
Collaboration with Development and Production Teams: Coordinate with development, engineering, production, and regulatory teams to ensure compliance with quality standards.
Failure investigations, PFMEA management, MRB committees, and more.
Requirements:
Education: Bachelors degree in Electronics Engineering, Industrial Engineering, Systems Engineering, or a relevant engineering field.
Professional Experience: At least 5 years of experience in a similar role, particularly in companies developing multi-disciplinary products (hardware, software, and electronics).
Experience in a multidisciplinary manufacturing company Must
Experience in defense Sector in a similar job- Must.
Experience working with strict quality standards and certifications, including defense-specific standards such as MIL-STD, AS9100, or similar.
Quality Certifications: Certifications in quality management (ISO 9001) are a plus.
Project Management Skills: Ability to manage quality-related projects, organize processes, and handle technological challenges.
Technological Skills: Experience with quality management systems, ERP and tools related to hardware and electronics.
Personal Skills: Analytical thinking, problem-solving abilities, ability to work under pressure, and excellent communication skills with internal teams and suppliers.
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
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עדכון קורות החיים לפני שליחה
8147794
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תודה על שיתוף הפעולה
מודים לך שלקחת חלק בשיפור התוכן שלנו :)
27/04/2025
חברה חסויה
Location: Tel Aviv-Yafo
Job Type: Full Time
Gauzy (NASDAQ: GAUZ) is a world-leading material science company, focused on the research, development, manufacturing, and marketing of vision and light control technologies that support safe, sustainable, comfortable, and agile user experiences across various industries. We are seeking an experienced Quality Assurance Manager to lead our quality initiatives and ensure compliance with global standards. This role is integral to maintaining our high manufacturing standards, driving continuous improvement, and collaborating with cross-functional teams to enhance product quality and performance. Joining Gauzy means becoming part of a cutting-edge, fast-growing company that values innovation, excellence, and teamwork in shaping the future of smart materials. *** Please send a copy of your CV in English.

Responsibilities:

* Drive quality performance and continuous improvement across the organization.
* Develop and implement product quality assurance strategies across all development phases.
* Define QA compliance objectives and ensure adherence to international standards (ISO 9001, VDA 6.3, IATF 16949).
* Establish quality control methods, documentation, and risk management practices (FMEA, APQP, PPAP, SPC, MSA).
* Investigate root causes of deviations with R&D and production teams, ensuring corrective actions.
* Oversee supplier evaluations, internal audits, and customer compliance audits.
* Train and supervise technical staff in quality processes, testing, and reporting.
* Serve as the product safety representative and liaise with global quality teams.
* Prepare for and manage internal, customer, and certification audits.
* Willingness to travel internationally when required.
Requirements:
* Minimum of 5 years of quality assurance experience in production processes within a manufacturing company
* Experience in implementing and managing quality assurance metrics
* Familiarity with ISO 9001:2015 regulations, automotive industry standards (IATF 16949, VDA 6.3), CAPA, and automotive core tools (e.g., FMEA, APQP, PPAP, SPC, MSA)
* Excellent problem-solving, interpersonal communication, and project management skills (8D, Ishikawa, 5W)
* Ability to lead cross-functional organizational processes
* Certified 1st and 2nd party auditor for IATF 16949; VDA 6.3 auditor certification preferred
* Strong technical skills
* Proficiency in Microsoft Office tools, particularly Excel
* High proficiency in written and spoken English
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
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עדכון קורות החיים לפני שליחה
8092785
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תודה על שיתוף הפעולה
מודים לך שלקחת חלק בשיפור התוכן שלנו :)
6 ימים
חברה חסויה
Location: Tel Aviv-Yafo
Job Type: Full Time
We are seeking an experienced Quality Assurance Manager to lead our quality initiatives and ensure compliance with global standards. This role is integral to maintaining our high manufacturing standards, driving continuous improvement, and collaborating with cross-functional teams to enhance product quality and performance.

Joining us means becoming part of a cutting-edge, fast-growing company that values innovation, excellence, and teamwork in shaping the future of smart materials.

*** Please send a copy of your CV in English.

Responsibilities:
Drive quality performance and continuous improvement across the organization.
Develop and implement product quality assurance strategies across all development phases.
Define QA compliance objectives and ensure adherence to international standards (ISO 9001, VDA 6.3, IATF 16949).
Establish quality control methods, documentation, and risk management practices (FMEA, APQP, PPAP, SPC, MSA).
Investigate root causes of deviations with R&D and production teams, ensuring corrective actions.
Oversee supplier evaluations, internal audits, and customer compliance audits.
Train and supervise technical staff in quality processes, testing, and reporting.
Serve as the product safety representative and liaise with global quality teams.
Prepare for and manage internal, customer, and certification audits.
Willingness to travel internationally when required.
Requirements:
Minimum of 5 years of quality assurance experience in production processes within a manufacturing company.
Experience in implementing and managing quality assurance metrics.
Familiarity with ISO 9001:2015 regulations, automotive industry standards (IATF 16949, VDA 6.3), CAPA, and automotive core tools (e.g., FMEA, APQP, PPAP, SPC, MSA).
Excellent problem-solving, interpersonal communication, and project management skills (8D, Ishikawa, 5W).
Ability to lead cross-functional organizational processes.
Certified 1st and 2nd party auditor for IATF 16949; VDA 6.3 auditor certification preferred.
Strong technical skills.
Proficiency in Microsoft Office tools, particularly Excel.
High proficiency in written and spoken English.
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
עדכון קורות החיים לפני שליחה
עדכון קורות החיים לפני שליחה
8163120
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תודה על שיתוף הפעולה
מודים לך שלקחת חלק בשיפור התוכן שלנו :)
03/04/2025
חברה חסויה
Location: Tel Aviv-Yafo
Job Type: Full Time and Hybrid work
We are offering you to take a vital role in our research team that is responsible for constantly driving forward our ability to detect accessibility issues, enhancing the intelligence of our platform to provide customers with insights and usability enhancements that allow them to work more efficiently, and building innovative new products

To achieve those ends the team employs classic algorithms, data analysis, machine learning and generative AI.

You will be joining a team of highly professional and innovative engineers and scientists that are driven by passion for the domain and the mission of the company. We value scientific and engineering excellence, are committed to creating high impact products that reach our customers and work in collaboration with each other in an egoless environment.

Your Impact:
Research, design and implement new detection algorithms for web accessibility issues and improve existing ones.
Ensure all research is well documented and reproducible.
Build and enhance tools that enable data collection, labeling and analysis at scale for research purposes.
Integrate new models and algorithms into existing products.
Build interfaces for projects in the POC phase to enable demonstration and the collection of feedback from internal users and select design partners.

Were based in Tel Aviv, 5 minutes from Hashalom train station, and Yehudit light train station, and we have our own parking lot. We work in a hybrid mode, with flexible working hours.
Requirements:
3+ years of experience in modern web-scale runtimes/languages, specifically Node (Typescript/JavaScript).
Ability to write and reason about clean and modular code.
Experience with front-end web development including component development - advantage.
Experience with accessibility - advantage.
Experience working with data science/research/AI teams - advantage.
BA / BSc in computer science or a quantitative field (Industrial Engineering and Management / Information Systems / Economics / Statistics / Mathematics / Biology / Physics / Chemistry) or an equivalent experience.
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
עדכון קורות החיים לפני שליחה
עדכון קורות החיים לפני שליחה
8127611
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דיווח על תוכן לא הולם או מפלה
מה השם שלך?
תיאור
שליחה
סגור
v נשלח
תודה על שיתוף הפעולה
מודים לך שלקחת חלק בשיפור התוכן שלנו :)
03/04/2025
חברה חסויה
Location: Tel Aviv-Yafo
Job Type: Full Time and Hybrid work
We are offering you to take a vital role in our research team that is responsible for constantly driving forward our ability to detect accessibility issues, enhancing the intelligence of our platform to provide customers with insights and usability enhancements that allow them to work more efficiently, and building innovative new products

To achieve those ends the team employs classic algorithms, data analysis, machine learning and generative AI.

You will be joining a team of highly professional and innovative engineers and scientists that are driven by passion for the domain and the mission of the company. We value scientific and engineering excellence, are committed to creating high impact products that reach our customers and work in collaboration with each other in an egoless environment.

Your Impact:
Research, design and implement new detection algorithms for web accessibility issues and improve existing ones.
Ensure all research is well documented and reproducible.
Build and enhance tools that enable data collection, labeling and analysis at scale for research purposes.
Integrate new models and algorithms into existing products.
Build interfaces for projects in the POC phase to enable demonstration and the collection of feedback from internal users and select design partners.

Were based in Tel Aviv, 5 minutes from Hashalom train station, and Yehudit light train station, and we have our own parking lot. We work in a hybrid mode, with flexible working hours.
Requirements:
3+ years of experience in modern web-scale runtimes/languages, specifically Node (Typescript/JavaScript).
Ability to write and reason about clean and modular code.
Experience with front-end web development including component development - advantage.
Experience with accessibility - advantage.
Experience working with data science/research/AI teams - advantage.
BA / BSc in computer science or a quantitative field (Industrial Engineering and Management / Information Systems / Economics / Statistics / Mathematics / Biology / Physics / Chemistry) or an equivalent experience.
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
עדכון קורות החיים לפני שליחה
עדכון קורות החיים לפני שליחה
8127585
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דיווח על תוכן לא הולם או מפלה
מה השם שלך?
תיאור
שליחה
סגור
v נשלח
תודה על שיתוף הפעולה
מודים לך שלקחת חלק בשיפור התוכן שלנו :)
מיקום המשרה: תל אביב יפו
סוג משרה: משרה מלאה
למחלקת כירורגיה - מחלקת השתלות והפטוביליארית דרוש.ה חוקר.ת
לניהול עצמאי של מחקר, מרמת המודל העכברי ועד ניתוח והצגה של מאפיינים מולקולריים.
המחלקה עוסקת בטיפול ייעודי רב-תחומי בחולי כבד, דרכי מרה ולבלב וחולים הנזקקים להשתלות כליה, כבד או לבלב ובמחקר.
עבודה עם עכברים.
היקף משרה:
משרה מלאה, א'-ה'.
8 שעות עבודה ביום.
דרישות:
השכלה: תואר מתקדם במדעי החיים.
ידע מעשי בעבודה על מכשור רלוונטי: FACS, RT-PCR, IVIS .
ניסיון בגידול של תאים וחיידקים, אנליזות סטטיסטיות והצגה של תוצאות.
נכונות לעבודה עם עכברים. המשרה מיועדת לנשים ולגברים כאחד.
 
עוד...
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