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Quality Assurance Engineer for a Medical Device Start-Up
I'm looking for a motivated and detail-oriented Expirienced Quality Assurance (QA) Engineer. This is an exciting opportunity for someone looking to advance their career in quality assurance within the medical device industry. In this role, you will support the implementation and maintenance of our Quality Management System - QMS, ensuring compliance with regulatory standards such as ISO 13485 and 21 CFR Part 820. You will work closely with cross-functional teams to help maintain quality processes, conduct inspections, and contribute to continuous improvement initiatives. This is an excellent opportunity to gain hands-on experience in a fast-paced, innovative startup environment while working on medical devices that make a real difference in patients' lives. Key Responsibilities • Assist in maintaining the Quality Management System - QMS to ensure compliance with ISO 13485 and 21 CFR Part 820. • Lead quality control activities, including incoming inspections, documentation writing and reviews, and final product release. • Monitor and track nonconformities, customer complaints, and corrective and preventive actions (CAPA). • Participate in internal audits, ensuring corrective actions are followed up and documented properly. • Collaborate with engineering and manufacturing teams to ensure quality requirements are met throughout the development process. • Assist in writing and maintaining regulatory documentation and records to support compliance efforts. • Support supplier quality assurance activities by helping review and track supplier performance. • Contribute to continuous improvement initiatives by identifying areas for enhancement in quality processes. Location: Haifa (on site)
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Operations & Manufacturing Manager
We are seeking a highly motivated and experienced Operation and Manufacturing Manager to lead the manufacturing, supply chain, and operational activities in the company. This role is critical to ensuring efficient, high-quality, and scalable production that supports the company’s fast growth and strategic goals. The ideal candidate will bring strong leadership, hands-on manufacturing experience, supply chain management capabilities, and a continuous improvement mindset. The position requires close collaboration with R&D, QA, logistics, and external vendors to ensure smooth and cost-effective operations. LOCATION: Yokneam, Israel. SCOPE & RESPONSIBILITIES Lead and manage all manufacturing activities, ensuring efficiency, quality, and adherence to regulatory requirements. Oversee daily operations, including production, inventory, warehouse, purchasing, and end-to-end supply chain management. Drive improvements in operational systems, processes, and policies to support the company mission to become a profitable neurovascular company. Manage subcontractors and external suppliers to ensure timely and cost-effective delivery of components and services. Analyze performance metrics, financial reports, and operations data to identify areas for improvement and cost reduction. Participate in long- and short-term operational planning to align manufacturing and supply chain capabilities with company goals. Build, manage, and mentor the manufacturing team, including recruiting, training, and performance management.
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CEO / CTO for Early-Stage Pharma Startup
I'm seeking a hands-on and visionary CEO/CTO to lead a newly formed pharmaceutical startup from inception through early development stages. The selected candidate will oversee scientific and operational activities, including drug R&D, regulatory strategy, and preclinical studies, while also building the business and strategic foundations for future growth. Key Responsibilities: Develop and implement the company’s strategic and business roadmap Lead and manage all aspects of the company’s development Oversee non-clinical research and development, including work with CROs Design and manage IND-enabling studies and regulatory planning Build relationships with external partners Manage timelines, budgets, and incubator-related activities
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מנהל/ת מרכז תשתיות ביו רפואיות
הובלה ופיתוח משאבים של מרכז תשתיות מחקר ביו-רפואי, כולל מחקר בסיסי. ניהול ופיתוח צוות המרכז. הנגשת שירותי המרכז לחוקרים - תמיכה, הדרכה וסיוע לחוקרים וסטודנטים בהקמת מערכי ניסוי ייעודיים ובשימוש במתקני המרכז לניסויים. תמיכה בקורסי הוראה מתקדמים ובמעבדות הוראה. התאמה הכוונה וייעוץ לרכש תשתיתי עתידי. סיוע בכתיבת מענקי מחקר, קולות קוראים וכתיבת מאמרים. עבודה מול מרכזים מחקריים אחרים בארץ ובעולם. ניהול תקציבים של המרכז, כולל חיוב תקציבי משתמש, רכש ואדמיניסטרציה כללית. אחריות וניהול תחזוקת הציוד ותשתיות המרכז – תחזוקה, תפעול, בטיחות .
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CTO
I'm Hiring: CTO for a Medical Incubator company Location: Northern Israel Type: Full-time Descripition: This is a seed-stage incubator company, with limited resources - the CTO is required to be hands-on. Chief Technology Officer (CTO) Leads product development from concept to clinical validation, managing engineers, consultants, and manufacturing partners. Continuous monitoring of the product’s resources, budget and timeline
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CEO
I'm Hiring: CEO For a Medical Incubator company Location: Northern Israel Type: Full-time Descripition: This is a seed-stage incubator company, with limited resources - the CEO is required to be hands-on. Leading the company's R&D efforts. Building and implementing a detailed R&D program and work plan to fulfill the company's development objectives. Working to improve and expand the company's novel innovation. Developing prototypes of products based on the company's technology. Collaborating with medical professionals to run pre-clinical and clinical testing of prototypes. Managing internal and subcontractors. Hosting audits from third parties and regulatory agencies.
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Regulatory Affairs Specialist
Responsibilities: •Provide regulatory support to the Development and Post marketing activities related to the company products. •Preparation and maintenance of regulatory submissions and registrations of the company products in relevant markets. •Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation •Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses. •Review of customer complaints to determine reportability according to regulatory requirements and execution of reporting per determination. •Provide ongoing regulatory support and assessments to different QMS related processes (e.g. MRB, CAPA, Contract review) •Actively participate in the evaluation of changes to the QMS documents and device design/process for impact on pending or existing registrations •Provide support for all external/internal audits at HQ and globally, as needed •Advise project teams on premarket regulatory requirements, labeling requirements and/or other compliance issues. •Work closely with various other teams (e.g. R&D, Operations, Quality, Marketing) both locally and around the world, to provide regulatory inputs as needed. •Monitor and advise the organization of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure ongoing regulatory compliance •Attend other regulatory related needs, as required •Working according to Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.
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CEO for an innovative startup in the field of molecular diagnostics
Overview: The CEO will be responsible for the company's overall strategic direction, leadership, and management. This includes driving business growth, overseeing operations, fostering a culture of innovation, and ensuring financial stability. The ideal candidate will have a strong background in biotechnology, molecular diagnostics, and healthcare, coupled with extensive executive leadership experience. Key Responsibilities: • Develop and execute the company's long-term strategy per its vision and mission. • Identify and pursue new business opportunities, partnerships, and markets. • In-depth vision of the market and competitor landscape • Maintain strong relationships with key stakeholders, including investors, partners, healthcare providers, and regulatory bodies. • Oversee day-to-day operations, ensuring efficiency and effectiveness in all business activities. • Implement robust processes and systems to drive operational excellence. • Manage the company's financial health, including fund raising, budgeting, forecasting, and reporting. • Oversee the research and development team to ensure the successful execution of the company's R&D strategy. • Foster a culture of innovation, encouraging the development of new diagnostic technologies and products. • Navigate the FDA approval process, ensuring all products meet regulatory requirements. • Develop and maintain strong relationships with regulatory agencies. • Build and lead a high-performing executive team, providing mentorship and development opportunities. • Cultivate a positive and collaborative work environment. • Drive market penetration and growth through strategic sales initiatives • Develop and implement sales strategies targeting hospitals, HMOs, and other healthcare providers. Location: Sharon District, Israel
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Senior Quality Assurance Engineer
Description: This position will be involved in production quality and quality aspects of NPI (New Product Introduction) processes. Responsibilities include customer and supplier interface, such as: Documentation and handling of customer complaints. Management of internal and supplier-related non-conformities (NCMRs). Leading CAPA processes, including in-depth investigations using standard methodologies such as 5Y, Fishbone, process flow mapping. Preparation and coordination of Change Orders, including cross-departmental communication through to release. Advantage: Experience with statistical tools for data analysis. Responsibility for overseeing the annual audit plan and conducting internal audits. Collaboration with all departments within the organization, including: Production, Engineering, Planning & Control, Procurement, Business Development, HR, and Finance, as well as external interfaces such as customers and suppliers.
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Pharmaceutical QP-RP
Responsibilities as QP: - Releasing cartridge production batches to the market after approval of quality assurance, ensuring compliance with regulatory and quality requirements, adhering to Eudralex volume 4, annex 16, guidelines. - Batch release approval documents will be personally kept by the QP, available for authorities review, for a period of no less than 5 years. - Supervision of the production of proprietary plant-based inhalation products. - Change controls regarding manufacturing process review and, when applicable, plan approval. - Participate in solving quality issues and deviations in production. Responsibilities as RP: - Contact with the relevant district pharmacist on issues related to the production or release of products. - Controlled substances inventory log management. - Annual report to the IMCU: Preparation of annual reports for submission to the district pharmacist. - Control over the receipt of raw materials requiring restricted access into the warehouse. - Supervising the preparation of shipments of finished products. - Preparation of rejected materials for destruction including full documentation. - Carrying out a monthly and annual inventory count of restricted materials. - Change controls regarding inventory management and procedural movement reviews and, when applicable, plan approval. - Control of procedures as needed. Location: Lower Galilee, Israel
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Electronics Engineer with RF Expertise
• Responsibility for hardware development from planning to testing • Design, develop, and test RF-based electronic boards. • Operate and analyze results using laboratory test equipment, with a focus on VNA
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מנהל אחזקה ותשתיות
מנהל אחזקה ותשתיות אחראי על הובלת מדיניות האחזקה והטיפול בתשתיות ויישומה בפועל. עבודה בתיאום ובממשק קבוע עם מחלקות החברה השונות לצד קשר שוטף ומקצועי עם ספקיי החברה. התפקיד כולל: • מדיניות אחזקה: פיתוח והטמעה של אסטרטגיית אחזקה מקיפה הממקסמת את אחזקת הציוד ומשך זמן הפעילות של ציוד החברה והורדת סך הוצאות התחזוקה. • ניהול צוות: ניהול והובלת צוות טכנאי אחזקה, מתן הדרכה, הנחיה והערכת ביצועים על מנת להבטיח כישורים ויעילות ברמה גבוהה. • תחזוקת ציוד: פיקוח, ביצוע פעולות מונעות ונקיטה באמצעים מתקנים עבור כל המכונות, הציוד ומתקני החברה על מנת להבטיח את פעילותם במצב אופטימלי. • כיולים: ניהול מערך הכיולים של החברה. • ניהול תקציב: הכנה וניהול תקציב המחלקה כולל בקרת עלויות ותחזית הוצאות. • ניהול ספקים: ניהול קשרי עבודה עם ספקים ונותני שירות חיצונים, תיאום, ניהול מו"מ ועריכת הסכמים. • ניהול בטיחות: אחריות על התאמת פעילות תחזוקה עם נהלי בטיחות וקידום סביבת עבודה בטוחה עבור כל עובדי החברה. • הערכת נכסים: ניהול הערכת נכסים ומעקב אחר תחזוקת ציוד החברה כולל ניהול לוח זמנים להחלפת ציוד ו/או תחזוקתו. • שיפור מתמיד: זיהוי אזורים לשיפור תהליכים ויישום שיטות עבודה מומלצות לשיפור יעילות ואפקטיביות התחזוקה. • דיווח: הפקת דוחות ומחווני ביצועים מרכזיים (KPIs) למעקב אחר ביצועי תחזוקה והעברת תוצאות להנהלה הבכירה.
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Pilot Team Lead
Description: Leading the engineers and technicians in the ADL team and executing development and prototyping projects Responsibilities: Daily management of the Development team Management of customer order projects, including providing quote Adhering to schedules defined according to the group’s objectives Developing and improving production processes according to customer requirements Transition from development to production according to the prep methodology Providing technical solutions and working with engineers and technicians while meeting tight deadlines Collaborating with all company departments, including Production, Sales, Operations, and Quality Assurance Communication with clients and subcontractors (both domestic and international)
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Chief Product Officer
Your goal: Create a disruptive hardware/software radiology product for point-of-care clinical settings, including specifications, partner assessment, optimization, tradeoffs, prioritization, and execution, in collaboration with R&D, external partners, clinical team, and specialists (orthopedists, radiologists). You will do this by: Interacting with the potential market and stakeholders to understand and mobilize the psychology involved in bringing MRI capabilities to the point-of-care and embedding it in the current workflow. Coordinating regulatory, quality, and clinical requirements. Working closely with R&D teams in-house and with external partners as product owner, to deliver the product with optimal time-to-market, quality, and resources. Scoping and prioritizing activities based on business and customer impact. Serving as an in-house expert for our product and becoming the go-to person for all functional issues. Represent the voice of the customer within the company Long term: Collect and analyse feedback from customers, support, and other stakeholders to reshape requirements. Proactively engage customers, relevant internal stakeholders and key opinion leaders to provide input for product strategy and for planned functionalities, grow market share and improve customer experience. Drive new product launches.
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Quality Assurance Engineer
We are seeking a skilled and detail-oriented QA Engineer . The ideal candidate will be responsible for executing quality assurance activities, managing quality projects, and participating in process and product validations to ensure compliance with established standards and regulatory requirements. The QA Engineer will work closely with cross-functional teams to support quality projects, provide manufacturing support, and drive continuous improvement initiatives across the organization. SCOPE & RESPONSIBILITIES Manage ECOs: conduct risk assessment, update relevant DMR documents and carry out necessary IQ, OQ, PQ activities if required, finalization of implementation tasks. Manage DCOs in the PLM system: Write and update QA procedures to ensure compliance with quality standards and regulatory requirements. Manage NCR and CAPA processes: Lead, write and supervise the NCR and CAPA processes, ensuring timely and effective resolutions. Manage QA production activities: Provide quality support to production operations, addressing deviations and non-conformities to maintain high product quality. Ensuring Timely Resolution of Quality Issues: Promptly address all identified or assigned quality issues to prevent delays and maintain efficient operations. Participate in audits: Take part in internal and external audits, such as FDA inspections and notified body audits based on ISO13485, EUMDR, and MDSAP requirements. Location: Yokneam
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Adi Jobs
General position. Here you can submit your CV that will enter our database. We will reach out to you as soon as a position opens.
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Moran Jobs
General position. Here you can submit your CV that will enter our database. We will reach out to you as soon as a position opens.
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Hagit Jobs
General position. Here you can submit your CV that will enter our database. We will reach out to you as soon as a position opens.
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NPI Project Manager
Leading engineering projects - include planning facilities, purchasing, and absorbing new technologies for production. Planning and leading new technologies for new products from development to production Providing engineering support to the maintenance team. Working with external suppliers in Israel and abroad. Writing and execution of engineering validation documents for equipment/machines in the process of their training.
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