משרות והצעות עבודה

This role is responsible for ensuring compliance, quality, and operational excellence throughout the development and manufacturing of Class III medical devices. Responsibilities • Lead, mentor, and manage the QA team, including task prioritization and performance development • Maintain and continuously improve the Quality Management System in compliance with ISO 13485, EU MDR, and FDA QSR (21 CFR 820) • Support Operations activities, including manufacturing, validation, MRB, CAPA, and supplier quality • Oversee CAPA, nonconformances, deviations, complaints, risk management, document control, and training processes • Prepare, implement, and maintain quality plans and annual quality activities • Actively participate in and support internal, supplier, and regulatory audits, including preparation, execution, and follow-up • Support regulatory submissions and interactions as required • Ensure quality oversight of QMS modules • Collaborate cross-functionally with R&D, Regulatory Affairs, Operations, and Clinical teams • Promote a strong culture of quality, compliance, and continuous improvement

Looking for a dynamic and experienced Director of Sales Europe, to lead sales efforts across Europe, consistently delivering Annual Recurring Revenue (ARR) targets. You will collaborate closely with Customer Success, Marketing, and Product teams for a leading Israeli software company. Role Overview Your primary focus will be overseeing sales activities and negotiations, fostering new business opportunities, and scaling subscription-based growth through complex B2B software-hardware integration projects. Tasks that you might work on include, but are not limited to: Enterprise Growth: Be the driving force behind efforts to generate new Enterprise business opportunities, overseeing the entire B2B sales cycle. Customer Base Expansion: Strategically expand the customer base through effective relationship-building using a consultative sales approach. Client Engagement: Identify and comprehend the strengths and needs of the existing client pipeline, ensuring tailored solutions that meet their requirements. On-Site Visits: Plan and execute successful on-site visits with prospective customers, fostering trust and collaboration. Product Demos: Conduct compelling online product demonstrations that showcase the value of the company's software integration platform. Contract Negotiations: Lead contract negotiations to secure mutually beneficial agreements.

• Conduct Incoming Inspection, QC, and in-process control activities per procedure and product requirements. • Support product/Batch release. • Write, review, and approve procedures and work instructions. • Provide support in the maintenance and improvement of the QMS. • Participate in product quality investigations in support of CAPA and Nonconforming material processes. • Support continuous improvement activities to reduce product failure rates. • Reviewing data and conducting statistical analysis • Collaborate with other departments and CMs functions to ensure high-level quality standards. • Performing Internal and External Audits • Represent Quality in a core team of different projects. • Supporting activities required to ensure Subcontractors and Supplier’s compliance with Company’s requirements. • Evaluating and supporting Suppliers and subcontractors’ quality performance • Take an active role in reviewing and approving design and manufacturing changes. • Participate in ongoing processes to improve products and services. • Verify the compliance of the company’s quality and control system requirements with regulation standards and company’s policies.

In this role, you’ll work closely with cross-functional teams, execute day-to-day quality activities on the manufacturing floor and help drive continuous improvement in a hands-on, fast-paced environment. Responsibilities: • Manage ECOs: conduct risk assessments, 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. • Supplier Quality Management: Manage supplier qualification and performance monitoring, including SCAR management, and support supplier audits.

The Verification and Validation (V&V) Engineer is responsible for planning, executing, and reporting the verification and validation of the company’s products. The V&V process begins after completion of product bring-up and integration and ends when the product is ready for transfer to production. Product changes and improvements can occur during the V&V process. Responsibilities: Planning the V&V • Studying and understanding the product specifications and how customers use the product; verifying that product functional specifications are clear and testable • Writing test plans, including test scenarios and required test equipment, and presenting them for review • Defining the bug management methodology • Defining and obtaining the equipment needed to perform V&V • Coordinating with and managing external laboratories and service providers when necessary • Planning test report formats and presentations Executing the V&V • Doing the verification and validation according to the test plans • Reporting bugs, ensuring their closure, and re-testing to verify closure • Modifying test plans and test reports when required • Documenting test results with attention to detail and collecting objective evidence supporting product compliance and non-compliance • Ensuring that tests are clearly documented and repeatable by other qualified personnel Reporting the V&V Results • Writing comprehensive test reports including objective evidence and explanations of product status • Conducting reviews of test results, demonstrating test procedures, and re-testing when required • Ensuring that V&V documentation is clear and accessible to all stakeholders

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. * שליחת קורות חיים למשרה זו מהווה אישור לשמירתם במאגר המידע של סטפ אפ קריירה, לצורך טיפול במשרה זו ו/או משרות נוספות. בכל שלב תוכל.י לבקש עיון או מחיקה

• Overall responsibility for the Quality Management System, including ownership and leadership of QMS processes such as CAPA, Complaints, Document Control, Training, Internal and External Audits, and Supplier Quality • Lead, maintain, and continuously improve the QMS to ensure compliance with applicable regulatory and quality standards • Manage and develop QMS processes and procedures, ensuring effective implementation across the organization • Monitor and assess QMS performance, identify gaps and improvement opportunities, and drive corrective and preventive actions • Prepare and present QMS-related data and metrics for Management Review and quality forums • Lead internal audits and support external and regulatory audits • Provide professional guidance, training, and support to stakeholders on QMS-related topics

In this role, you’ll be a key partner to R&D, leading quality activities across new product development and design changes, while ensuring compliance with global regulatory standards. Lead design control activities throughout the product lifecycle (ISO 13485, 21 CFR 820). Review and approve design inputs/outputs, V&V protocols, and reports. Maintain and execute risk management activities (ISO 14971), including FMEAs. Support EO sterilization and packaging validation activities (ISO 11135 / ISO 11607). Support root cause investigations, CAPAs, and engineering changes. Ensure design documentation is support for global regulatory submissions. Work closely with R&D, Operations, and Regulatory in a fast-paced, collaborative environment. Support internal and external audits as needed.

1. Manufacturing Process Support • Monitor daily production activities, troubleshoot issues, and provide timely technical support to maintain output and product quality. • Optimize manufacturing processes through root-cause analysis, cycle-time reduction, and waste elimination. • Develop and maintain work instructions and Test Instructions. • Collaborate closely with production and engineering teams Resolve process challenges within production facilities 2. Process Validation & Compliance – • Execute and document qualification/validation activities (IQ/OQ/PQ) per ISO 13485 and FDA 21 CFR 820 requirements. • Lead engineering investigation and Failure Analysis activities in Operation, on component, product or process level 3. Equipment & Tooling management • Validate new equipment, fixtures, and tooling. • Support preventive maintenance programs and collaborate with maintenance to ensure equipment uptime. • Perform equipment capability studies and implement improvements. • Lead engineering activity regarding design changes (ECO), NPI, test method and tooling design, monitoring and continuous improvement of manufacturing processes • Design new Jigs based on improvement recommendations. 4. Supports MRB processes in Operation, assisting with issues relating to CAPAs, complaints and manufacturing support

Manage and mentor a growing V&V team, fostering a culture of quality, accountability, and continuous improvement. Define and lead the V&V strategy, master plans, and schedules aligned to product development cycles and regulatory requirements. Coordinate V&V activities with external testing laboratories and vendors to ensure high-quality and timely deliverables. Champion continuous improvement of V&V tools, methodologies, and infrastructure. Oversee and execute verification and validation activities, including protocol design, testing, and documentation for capital systems and disposable devices. Ensure robust test method development, validation, and equipment qualification in accordance with industry and regulatory standards. Drive readiness for regulatory submissions and audits through comprehensive V&V documentation and compliance. Partner closely with R&D, Quality Assurance, Regulatory Affairs, Clinical, and Manufacturing teams to ensure integrated and risk-based V&V planning. Actively participate in design reviews, risk assessments (per ISO 14971), and contribute to the development and maintenance of DHF and DMR. Ensure all V&V activities comply with applicable regulatory standards, including FDA, ISO 13485, ISO 14971, IEC 60601, and EU MDR.

As the company first AI Solutions Resource, you will establish the AI framework and drive enterprise wide implementation of the AI Work Intelligence Platform, fine tune its agents for Quasar specific processes and build internal capabilities so teams can iterate with minimal vendor reliance. Success in this role hinges on your deep understanding of large language models (LLMs) and your ability to build effective tooling in low code environments Responsibilities: - Platform Advocacy: Champion AI platform implementation across all functions of the company. Host demos, roadshows and AI “office hours”; create playbooks and case studies. - MLOps & Performance: Build dashboards for model accuracy, latency and cost; automate retraining loops and internal benchmarking. Own release management, rollback plans and validation protocols. - System Configuration: Perform light configuration of the platform, such as adjusting role based access controls, workflow parameters, feature flags and integration end points, so new use cases can be launched quickly without heavy code changes. - Data Integration: Securely connect platform to MES, ERP, PLM and eQMS data while enforcing the company’s data-governance policies. - Change Management: Establish an AI Center of Excellence; design curricula for operators, engineers and executives. Document case studies showing cycle-time reduction, scrap reduction and audit-readiness gains. - Governance & Compliance: Define guardrails for IP critical tasks and data; ensure zero deviations in internal and external audits. Establish an enterprise wide AI governance framework (policies, risk assessments, ethics reviews).

Experienced and visionary CEO to lead an early-stage pharmaceutical company developing an innovative drug product. This is a unique opportunity to shape the strategy, secure the funding, and lead the development of a high-potential therapeutic candidate. Key Responsibilities: • Define and execute the company’s strategic and operational plans, in alignment with the Board’s vision. • Lead the company’s fundraising efforts, including interactions with VCs, angel investors, and strategic partners. • Establish strategic collaborations and co-development agreements with pharma and biotech partners. • Oversee and manage all R&D activities, including budget, timeline, and milestone tracking. • Lead the non-clinical development of the company’s lead asset. • Develop and adjust the clinical and regulatory roadmap in collaboration with key experts and partners. This is a full-time, on-site position (not hybrid), based in the Northern District of Israel.

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. • שליחת קורות חיים למשרה זו מהווה אישור לשמירתם במאגר המידע של סטפ אפ קריירה, לצורך טיפול במשרה זו ו/או משרות נוספות. בכל שלב תוכל.י לבקש עיון או מחיקה

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. * שליחת קורות חיים למשרה זו מהווה אישור לשמירתם במאגר המידע של סטפ אפ קריירה, לצורך טיפול במשרה זו ו/או משרות נוספות. בכל שלב תוכל.י לבקש עיון או מחיקה