חזרה ללוח
QA Manager
חברה דיסקרטית
מיקום
שרון
תחום
מכשור רפואי
בכירות
ביניים
היקף משרה
משרה מלאה
גודל חברה
גדולה (200+)
סוג תפקיד
רגולציה
תיאור המשרה
Position Overview
We are is seeking a QA/QC Manager to lead Quality Assurance and Quality Control activities supporting the development and manufacturing of Class III cardiovascular implantable devices and delivery systems.
The role is responsible for maintaining an effective quality management system, overseeing quality control operations, and ensuring compliance with applicable requirements throughout the product lifecycle.
Key Responsibilities
· Lead and develop the QA/QC team, establishing priorities, responsibilities, and performance objectives.
· Maintain and improve the Quality Management System in accordance with ISO 13485 and applicable regulatory requirements.
· Oversee incoming, in-process, and final inspection activities, including acceptance criteria, inspection methods, and quality records.
· Ensure that product acceptance and release activities comply with approved specifications and procedures.
· Lead nonconformance investigations, root cause analysis, CAPA, and effectiveness verification.
· Provide quality oversight for manufacturing processes, design transfer, process validation, and engineering changes.
· Review and approve quality documentation, validation protocols and reports, work instructions, and change-control records.
· Oversee supplier quality activities, including qualification, monitoring, audits, and corrective actions.
· Plan and conduct internal audits and support external audits and regulatory inspections.
· Monitor quality metrics, identify trends, and drive improvements in product and process quality.
· Ensure effective traceability and control of manufacturing and inspection records.
· Collaborate with R&D, Manufacturing, Engineering, Regulatory Affairs, and global quality stakeholders.
Required Qualifications
· Bachelor’s degree in Engineering, Life Sciences, or a related discipline.
· Proven experience in Quality Assurance and Quality Control within the medical device industry.
· Direct experience with Class III medical devices, including implantable products, manufacturing quality, and validation activities.
· Experience managing quality teams and overseeing QA/QC operations.
· Strong working knowledge of ISO 13485 and applicable U.S. FDA and EU medical device requirements.
· Hands-on experience with CAPA, nonconformance management, change control, supplier quality, and audits.
· Experience reviewing process validation documentation, including IQ/OQ/PQ.
· Strong leadership, analytical, and problem-solving skills.
· Ability to work effectively across functions and balance operational priorities with quality requirements.
· Fluent English, with strong technical writing and communication skills.
Preferred Qualifications
· Experience with cardiovascular implants, stent grafts, catheters, or delivery systems.
· Experience with cleanroom manufacturing, sterile devices, packaging, and sterilization validation.
· Experience supporting FDA inspections, notified body audits, or products approved through the PMA pathway.
· Familiarity with ISO 14971 risk management principles.
· Experience working within a global medical device organization.
דרישות התפקיד
Position Overview
We are is seeking a QA/QC Manager to lead Quality Assurance and Quality Control activities supporting the development and manufacturing of Class III cardiovascular implantable devices and delivery systems.
The role is responsible for maintaining an effective quality management system, overseeing quality control operations, and ensuring compliance with applicable requirements throughout the product lifecycle.
Key Responsibilities
· Lead and develop the QA/QC team, establishing priorities, responsibilities, and performance objectives.
· Maintain and improve the Quality Management System in accordance with ISO 13485 and applicable regulatory requirements.
· Oversee incoming, in-process, and final inspection activities, including acceptance criteria, inspection methods, and quality records.
· Ensure that product acceptance and release activities comply with approved specifications and procedures.
· Lead nonconformance investigations, root cause analysis, CAPA, and effectiveness verification.
· Provide quality oversight for manufacturing processes, design transfer, process validation, and engineering changes.
· Review and approve quality documentation, validation protocols and reports, work instructions, and change-control records.
· Oversee supplier quality activities, including qualification, monitoring, audits, and corrective actions.
· Plan and conduct internal audits and support external audits and regulatory inspections.
· Monitor quality metrics, identify trends, and drive improvements in product and process quality.
· Ensure effective traceability and control of manufacturing and inspection records.
· Collaborate with R&D, Manufacturing, Engineering, Regulatory Affairs, and global quality stakeholders.
Required Qualifications
· Bachelor’s degree in Engineering, Life Sciences, or a related discipline.
· Proven experience in Quality Assurance and Quality Control within the medical device industry.
· Direct experience with Class III medical devices, including implantable products, manufacturing quality, and validation activities.
· Experience managing quality teams and overseeing QA/QC operations.
· Strong working knowledge of ISO 13485 and applicable U.S. FDA and EU medical device requirements.
· Hands-on experience with CAPA, nonconformance management, change control, supplier quality, and audits.
· Experience reviewing process validation documentation, including IQ/OQ/PQ.
· Strong leadership, analytical, and problem-solving skills.
· Ability to work effectively across functions and balance operational priorities with quality requirements.
· Fluent English, with strong technical writing and communication skills.
Preferred Qualifications
· Experience with cardiovascular implants, stent grafts, catheters, or delivery systems.
· Experience with cleanroom manufacturing, sterile devices, packaging, and sterilization validation.
· Experience supporting FDA inspections, notified body audits, or products approved through the PMA pathway.
· Familiarity with ISO 14971 risk management principles.
· Experience working within a global medical device organization.
על ענף התעשייה: מכשור רפואי
תחום המכשור הרפואי (Medical Devices) עוסק בפיתוח וייצור של מכשירים, אביזרים ותוכנות המשמשים לאבחון, ניטור, טיפול או מניעה של מצבים רפואיים שונים. התעשייה משלבת בין עולמות ההנדסה, הפיזיקה, הביולוגיה והרפואה הקלינית, ומגוון המוצרים נע בין מזרקים פשוטים ואביזרים כירורגיים ועד למערכות הדמיה מתוחכמות, שתלים חכמים ורובוטיקה רפואית. בישראל קיים אקו-סיסטם ייחודי ומוביל של חדשנות בתחום זה.
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