Qualifications: Experience the life sciences or similarly regulated industry (In-vitro Diagnostics preferred) A practical understanding of record audit and material approval processes per ISO13485:2106 for the Design and Manufacture of In-vitro Diagnostics Experience with an Enterprise Resource Planning System (ERP) Experience with Electronic Document more »
Qualifications: Demonstrated experience in the design and development of products - Medical industry advantageous Design or Engineering Degree preferred Familiarity with regulatory standards and QMS - ISO13485 advantageous CAD proficient, preferably Solidworks Plastic manufacturing process knowledge If you want to be part of a team dedicated to making a meaningful impact in more »
within a highly regulated environment. On site position Responsibilities include. Actively seeking opportunities to improve product and process quality. Maintaining knowledge of quality standards (ISO13485) and promoting best industry practices. Competence in process validation techniques and regulatory requirements, including handling customer feedback and complaints. Liaising with both various stakeholders from more »
refrigeration specifications are feasible to source by connecting to suppliers and manufacturing operations Provide specific documentation related to product design to meet regulatory compliance: ISO 9001, 13485 and organization requirements Assist on quality complains from the field by providing technical support to identify root cause, short- and long … and heat transfer Design Engineer will have experience working in formalized phase-gate product development process, using Design tools such as DFM, FMEA and ISO 9001 design controls Experience on SolidWorks (CAD) If you would like to find out more about this Design Engineer opportunity, click the "APPLY NOW more »