6 of 6 ISO 13485 Jobs in Cambridge

on integration needs. Familiarity with integrating automated liquid handling solutions Participation in product development and experience with verification and validation activities for automation workflows; familiarity with regulated environments (e.g., ISO 13485, IVD, CLIA) is helpful but not required. Strong collaboration and communication skills, with the ability to work in fast-paced, cross-functional environments. Comfortable reprioritizing project work More ❯

spare parts inventory and oversee the incoming inspection of parts to ensure quality and availability. Ensure that all Repair Centre operations adhere to relevant industry standards and regulations (e.g., ISO 13485, 21 CFR). Ensure the health and safety of the Repair Centre team and any visitors, adhering to all safety protocols and regulations within the facility. Ensure … Proven track record in managing a heavily regulated service or manufacturing facility, preferably within the medical device industry. In-depth understanding of medical device quality and regulatory requirements, including ISO 13485, MDSAP, MDD/MDR, and 21 CFR. Comprehensive knowledge of health and safety requirements in a manufacturing, service, or laboratory environment, including COSHH guidelines and risk assessments. More ❯

code from general requirements. Experience with IOT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc). Experience of working within a Quality System ideally EN ISO 13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience: Degree in Electronics Engineering. At least 3-5 years of industrial experience in More ❯

high-performance electronic systems as part of a multidisciplinary R&D team. Key Responsibilities: Lead PCB design, schematic capture, and system-level integration (Altium/KiCAD) Ensure compliance with ISO 13485 and IEC 60601 for medical device safety Collaborate with software, mechanical, and chemistry teams on integrated solutions Analog/digital circuit design including low-noise and power More ❯

worldwide. As Endomag continues its journey within Hologic, this role offers the chance to lead quality assurance through meaningful growth and transformation. About the role: Endomag is certified to ISO 13485, MDSAP, EU MDR and has CE certification for a Class IIa, IIb and III medical devices. The job holder will lead our QA compliance team and be … and improvement Assure quality products and processes by enforcing quality standards and regulations and testing of materials and products by our virtual supply chain. Maintain the company’s MDR ISO 13485/MDSAP quality system and CE certification. Represent the company during audits by its Notified Body or other organisations Lead the QMS integration activities with Hologic Oversee … Experience working with or implementing eQMS systems Lead Auditor experience Experience of direct interaction with regulatory authorities would be desirable Full understanding of the ethos and 8 principles of ISO13485 Understanding and working knowledge of ISO14971 Quality and Process knowledge/experience around material and sterilisation compatibility processes. ISO10993, ISO11135, ISO11737 Knowledge and understanding of Validation requirements and processes Evidence More ❯

Good organisational and time management skills Good working knowledge of MS office Confidence working in digital systems and document control platforms Experience of working within a certified QMS (e.g. ISO 9001 or ISO 13485) Experience working within a technical or regulated product environment Personal Qualities Collaborative and actively shares own knowledge Enthusiastic with a positive outlook and More ❯