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Build and ship full-stack features in a regulated healthtech AI product that turns clinician consultations into verified documentation using speech-to-text and LLMs.
Digital Solution Manager Location: Lisboa Time Type: Full time Job Description ZEISS is technology and innovation. Founded in Germany, in 1846, ZEISS is an internationally leading technology enterprise operating in the…
Oversees medical device software documentation and regulatory compliance for cardiovascular imaging tools, bridging clinical needs with engineering teams to ensure EU MDR/FDA submissions and post-market surveillance.
Build and own Aidoc’s QA strategy from scratch for regulated AI medical-imaging products, designing test architecture, automating with Python/pytest/Playwright, and integrating CI/CD to meet FDA/ISO standards.
This is how you make an impact As QESH Manager, you will report directly to the Managing Director and serve as a member of the Management Team. You will be responsible for developing, implementing, monitoring, and…
Performs precision inspections and quality checks on medical equipment parts, documents results, and collaborates with engineers to resolve discrepancies in a regulated healthcare environment.
A Sr. QA Laboratory Engineer at Waters Corporation investigates molecular contamination, validates/test methods (e.g., mass spectrometry, liquid chromatography), and ensures product release compliance. They drive quality improvements, collaborate cross-functionally, and manage quality records in a lab-focused role.
In This Position, You Will Have the Opportunity To: Serve as the Quality Management Representative (QMR) for the manufacturing facility, including hosting third party audits and inspections, organizing and conducting…
Leads quality assurance for cardiovascular electrophysiology products, ensuring compliance with regulatory standards (FDA, ISO) and developing methodologies for hardware/software validation, risk assessment, and post-market sustaining activities.
The Quality Assurance/Regulatory Affairs Specialist maintains the company's Quality Management System and ensures compliance with ISO 13485 and cGMP standards. The role involves reviewing documentation, conducting audits, and managing corrective action plans within a diagnostic product environment.
The Quality Engineer will maintain and improve quality management systems in compliance with ISO and FDA standards for medical device manufacturing. The role involves conducting internal audits, managing document control, and overseeing CAPA processes to ensure operational efficiency.
Job Responsibilities: Lead and responsible for maintaining Plant procedure for Incoming Quality and all its associated procedures and forms, that complies with QMS structure. Oversee the creation, review and management…
Regulatory Compliance Lead all compliance activities for food-contact packaging materials and finished products. Interpret, implement, and maintain compliance with applicable regulatory requirements, including US FDA…
Project Engineer (CM) - Medical Devices Singapore | Project Engineering | Medical Device Manufacturing | ISO 13485 | FDA QSR | Contract Manufacturing | IQ/OQ/PQ SGD 3,000 – 4,500 Take ownership of engineering and…
The Test Engineer will develop verification plans and conduct mechanical testing for brachytherapy applicators in a medical device environment. The role involves documenting test results, managing deviations, and collaborating with cross-functional teams including development, risk management, and production.
The Senior Staff Design Quality Engineer provides technical leadership for medical device development, ensuring compliance with regulatory standards and managing risk throughout the product lifecycle. The role involves cross-functional collaboration, mentoring team members, and requires significant global travel.
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to…
The Test Engineer develops and executes mechanical test plans for medical radiation therapy applicators, ensuring product compliance with regulatory standards like IEC 60601 and ISO 13485. Daily work involves designing test setups, documenting results, and collaborating with engineering, risk management, and production teams.
Senior embedded firmware engineer developing real-time C/C++ firmware for medical-grade hardware, including RTOS integration, driver/BSP development, and ensuring compliance with IEC 62304, ISO 14971, and FDA 510(k) regulatory standards.
Designs and implements scalable, cloud-native software for in vitro diagnostic solutions, focusing on microservices, AWS infrastructure, and data pipelines while ensuring security and compliance.
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