Compliance Engineer -Scientific & Laboratory Systems
We are looking for an experienced Compliance Engineer to join a team of electro-mechanical, software and test engineers within a high-tech product development company based in Cambridgeshire. The Compliance Engineer will have an experience in product conformance, including knowledge of Machinery Directives, CE marking, the practical application of the EU Low Voltage, EMC, RoHS, Reach and WEEE Directives. Occasional travel overseas might be required.
â¢ Researching and applying regulatory standards such as CE, ATEX, NRTL, GMP or GAMP to the design and manufacture of sophisticated scientific laboratory equipment.
â¢ Working with CE and NRTL notified bodies e.g. UL, TUV, CSA etc
â¢ Maintaining a reference database of standards
â¢ Working with external compliance consultants
â¢ Introduction of new procedures and preparation of conformance documentation
â¢ Review tests and reports, creating Product Specifications, Tests, Risk assessments, DFMEA`s according to the company standards.
â¢ Visiting suppliers & customer sites to review manufacturing process and operation of equipment, continuous improvement.
â¢ Experience in international compliance and conformance within an industrial environment
â¢ Experience of CE marking and certifying products, Machinery Directives etc.
â¢ A good knowledge of current industrial electrical safety control methods and standards
â¢ Ability to understand engineering drawings and specifications
â¢ Self-motivated with the ability to plan workloads, balance multiple tasks and ensure involvement where required
â¢ Familiarity with Chemical or Pharmaceutical industries
â¢ Experience of Product Data Management systems (PDM, PLM)
â¢ Knowledge of pressure vessels and related directives
â¢ A working knowledge of GMP principles and processes
â¢ Experience of ATEX within industrial process environments
â¢ Familiarity with GAMP for automation and control systems
â¢ Ability to speak Japanese would be a particular advantage