3 of 3 ISO 13485 Jobs in Berkshire

or related field (or equivalent work experience). Previous experience in a fast-paced PCB fabrication environment required. Familiarity with quality systems such as ISO 9001, AS9100 or ISO13485 is a plus. If you are passionate about leading teams in a dynamic environment and possess the necessary skills, we encourage you to apply for this exciting opportunity as a More ❯

and product validation, iterating based on test results and feedback. Collaborate with suppliers on design reviews, ensuring cost-effective, reliable manufacturing. Ensure compliance with relevant regulatory and quality standards (ISO 9001, CE, RoHS, EMC considerations). Support root cause analysis and continuous improvement (CI) activities during and post NPI. Document processes and design changes, maintaining alignment with engineering change … understanding of DFM/DFA principles. Ability to work closely with cross-functional teams (electronics, firmware, quality, production). Experience in risk assessment, FMEA, and quality documentation aligned with ISO 9001 or similar. Comfort with prototyping, debugging, and iterative design. Nice to Have Experience in RFID/NFC, barcode scanners, or imaging devices mechanical design. Familiarity with ISO 13485, ISO 14971, or similar regulated environments. Exposure to Lean Manufacturing, Six Sigma methodologies. Experience designing test fixtures for production and QA. Familiarity with IP rating considerations for rugged devices. Why us? Work on real hardware products that ship globally. See your designs in use in airports, banks, and secure environments worldwide. Join a collaborative, engineering-led More ❯

maintaining a strong focus on customer satisfaction. Maintain organised records and ensure all documentation is archived in line with company policies. Follow all relevant procedures and quality standards, including ISO13485, ISO14001, and Medical Device Regulations. Engage in continuous improvement by completing all required training and Learning Management System (LMS) modules on time. Qualifications and Experience: Must be educated to a … at least 2 years' proven experience in a similar role. Excellent communication skills (written and verbal). Experience with SAP and Salesforce is highly desirable. Experience working in an ISO 13485 , 14001 and MDR regulated environment is desirable. Skills: IT Skills including the ability to use Microsoft Office at a proficient level. Good English in verbal and written More ❯