Trabajos iso en CambridgeCrear alertas

CPL Life Sciences are looking to recruit a Design Controls Engineer to join a global Pharmaceutical company based in Cambridge. This will be a 12 month contract role (PAYE), based on site in Cambridge. Responsibilities: • Lead design control and risk management activities for medical device combination product development, • Support effective design control and risk management activities internally, at external design companies, and at related manufacturing facilities/CMOs, • Generate and approve documentation, ensuring compliance with quality & regulatory standards (internal & external), • Provide support to design validation, • Support in internal & external audits where required Skills & experience: • Hold a relevant degree or proven experience working in a similar role, • Understanding of working to ISO 13485/ISO 14971/21 CFR 820/21 CFR 4, and the EU Medical Devices Regulation., • Experience in medical device combination products and/or medical devices, • Understand Good Manufacturing Practices (GMP). If interested, please apply directly or email your CV to

Job Title: Design Control and Risk Management Compliance Engineer Location: Cambridge, UK Department: Drug Product Design and Development (DPDD) Reports To: Design Control Lead Position Summary We are looking for a Design Control and Risk Management Compliance Engineer to join our Drug Product Design and Development team in Cambridge, UK. The role provides subject matter expertise in design control and risk management for medical device and drug-device combination product development throughout the product lifecycle. The successful candidate will ensure compliance with quality and regulatory requirements, support design validation, and collaborate closely with internal teams, external design partners, and manufacturing organizations. Key Responsibilities • Lead and oversee design control and risk management activities for medical device and combination product development programs., • Ensure design control and risk management documentation is authored, approved, and maintained in line with global regulatory and quality standards., • Provide support and guidance to cross-functional teams, external design companies, and manufacturing partners., • Contribute to design validation activities, including use-related risk assessments., • Support the preparation of regulatory submission data and content., • Assist with internal and external audits of Quality Management Systems. Essential Requirements • BSc or MSc in a relevant science or engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering, or related)., • Minimum 5 years’ experience in the medical device and/or pharmaceutical combination product industry., • Strong experience in design control and risk management for medical devices or combination products., • In-depth knowledge of regulatory standards including:, • ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU MDR., • Understanding of Good Manufacturing Practices (GMP)., • Excellent communication skills (oral, written, and presentation)., • Strong attention to detail, organizational skills, and ability to manage multiple projects., • Ability to work independently as well as in cross-functional teams., • Familiarity with Human Factors / Usability Engineering (EN 62366)., • Knowledge of device assembly and related manufacturing processes., • Experience with standards such as EN 60601 (electrical safety) and EN 62304 (software)., • Opportunity to work on innovative drug-device combination products., • Collaborative and supportive team environment., • Competitive salary and benefits package., • Professional growth and development opportunities.

Lead Manufacturing Engineer Location: Cambridgeshire Profectus have partnered with a UK-based manufacturer is seeking a skilled Lead Manufacturing Engineer to support its low-volume, high-complexity production operations. This is an ideal role for someone with a background in electro-mechanical manufacturing who thrives in a hands-on environment where precision, quality, and collaboration are paramount. The organisation operates in a niche but globally relevant sector, developing and assembling sophisticated systems used across scientific, healthcare, and research settings. With sustained growth and ongoing investment in new technologies, this is a strategic opportunity to step into a role where your experience and insight will directly shape operational success. The Opportunity This is a practical, on-the-ground position that will see you working at the intersection of production, engineering, procurement, and logistics. You’ll be a key player in maintaining process integrity, resolving day-to-day technical issues, and ensuring consistent product output in a regulated, small-batch production setting. You’ll be instrumental in process optimisation, new product introductions, and ensuring compliance with quality standards. The role also involves mentoring others and fostering a culture of continuous improvement across the shop floor. Key Areas of Responsibility Production & Process Development: • Refine and maintain build processes for low-volume electromechanical assemblies, • Lead troubleshooting of technical issues impacting build quality or throughput, • Support commissioning of new products and the transition from design to production, • Support adherence to ISO standards and internal QMS procedures, • Coordinate compliance efforts related to electrical safety and materials handling, • Guide junior engineering and production staff on process expectations, • Contribute to cross-functional initiatives around new product launches, • Identify and drive improvements in efficiency, consistency, and waste reduction Candidate Profile We’re looking for a confident, proactive manufacturing engineer who combines technical depth with strong communication and a collaborative mindset. The ideal candidate will have: • A degree in Manufacturing, Mechanical, or Industrial Engineering (or similar), • 3+ years’ experience in a manufacturing engineering role within a low-volume, electromechanical environment, • Experience working to CE marking standards (knowledge of international equivalents is a plus), • A background in regulated sectors such as medical, laboratory, or scientific equipment is beneficial, • Demonstrated ability to support and lead cross-functional teams, • Strong analytical skills, attention to detail, and a practical, hands-on approach Please apply with an up to date version of your CV for immediate consideration.

An established and respected building services provider is seeking an enthusiastic, skilled.Based in either Cambridge, Northampton or Norwich, the successful candidate will support project teams with ISO 19650 compliance, MEPH design processes, BIM clash detection, BIM site verification, COBie manag

This consultancy team work on a range of medical device products and technologies, from drug delivery systems to sophisticated medical instrumentation. Project experience with medical device products including regulatory standards and practices (such as ISO 13485, cGxP and ALCOA+). Experience in a c

Ensure continuous compliance with ISO accreditations including ISO9001, 45001 & 27001. Understanding of ISO accreditations, specifically ISO9001, 45001 & 27001. ISO Compliance Specialist | £37,500 | Occasional days onsite.

Deliver ISO 9001, ISO 14001, and ISO 45001 Lead Auditor training courses in line with globally accreditation requirements. ISO 9001 Quality, 14001 Environmental, and 45001 Occupational Health & Safety Management Systems. Ensure course content is delivered accurately, in an interactive and practical

ISO 27001, ISO 9001, ISO 14001, ISAE 3402, SOC2. ISO 27001 Lead Auditor, ISO 9001 Lead Auditor.

We are seeking a freelance trainer fluent in English to deliver ISO/IEC 27001 Lead Implementer and Lead Auditor courses. Deliver ISO/IEC 27001 LI and LA training courses in Dutch and English. Stay up to date with ISO standards and certification requirements.

ISO 27001, ISO 9001, ISO 14001, ISAE 3402, SOC2. ISO 27001 Lead Auditor, ISO 9001 Lead Auditor.

Professional experience and familiarity with specifically ISO 27001, while ISO 9001, SOC 1, SOC 2, and other auditing standards are also plusses. Align MRI's overall security strategy with internal teams, industry best practices, and global legislation, including but not limited to SOC 1, SOC 2, ISO

ISO 27001, ISO 9001, ISO 14001, ISAE 3402, SOC2. ISO 27001 Lead Auditor, ISO 9001 Lead Auditor.

ISO 27001, ISO 9001, ISO 14001, ISAE 3402, SOC2. ISO 27001 Lead Auditor, ISO 9001 Lead Auditor.

ISO 27001, ISO 9001, ISO 14001, ISAE 3402, SOC2. ISO 27001 Lead Auditor, ISO 9001 Lead Auditor.