Masters or foreign equivalent degree in Biomedical Engineering, Mechanical Engineering, or in a related engineering field of study Will accept a Bachelors degree with at least 5 years of related progressive professional product stewardship, quality, RD, operations, technical support or regulatory experience in lieu of a Masters degree. Each alternative requirement with at least 1 year of experience in i ensuring compliance with geographyspecific restricted substance requirements, including RoHS, REACH, and EU MDR, and company Restricted Substance Management RSM requirements; ii ensuring part, packaging, and product information is accurately tracked in database; iii authoring reports, including CMR carcinogenic, mutagenic or toxic for reproduction and MOI materials of interest; iv implementing Six Sigma based improvements for existing processes andor new process designs for REACH EC 19072006, RoHS EU Directive 201165EU and EU 2015863, California Prop65 and other material compliance regulations; and v ensuring compliance with U.S. Food and Drug Administration FDA regulations and other regulatory requirements, including FDA 21 CFR 820, ISO 13485, and ISO 14001; vi overseeing change management of implementing EU MDR EU 2017745 regulation for material compliance element; vii working with component suppliers on procuring information for RSM requirements and facilitating compliance with all RSM reporting requirements; viii implementing and integrating RSM evaluations; and ix facilitating, tracking, and working with various groups on component changes in the manufacture, import and distribution of any new product or relocation of manufacturing processes. Employer will accept any suitable combination of education, training, or experience.
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