Ken Grade

Background

About Ken Grade

Black Diamond’s Quality Engineering services group is dedicated to supplying the quality, safety, validation, regulatory and compliance experts that ensure clients’ medical devices, medicines, delivery systems and therapeutic products are the safest and most reliable in the world. Within this technology segment, our industry knowledgeable recruiters have rigorously and persistently sought out the most highly-specialized and proficient talent nationwide making our Quality group uniquely qualified to respond quickly and confidently to client’s critical contract resource needs. Specialties:Regulatory Affairs 510k submissions, IDE, AER’s, PMA’s, remediation/resolution, Validation: validation protocols (IQ, OQ, PQ); validation master plans;(LIMS);(SOP); process validation; facility qualification;(CSV); equipment qualification; utility systems validation; cleaning validation; TMV; packaging validation; 21 CFR Part 11.Quality: Gap/ Risk assessment; MDR’s, Documentation, CE marking, international standards, complaint handling; auditing; QSIP, vendors, deviation; CAPA, design control. Black Diamond’s Mechanical Engineering & Design Services group supplies on-demand engineering resources related to the analysis and design of mechanical based devices, structures and systems for a wide range of industries including aerospace, automotive, industrial equipment and medical devices. With a combined 70+ years of national market, mechanical engineering recruiting and account servicing experience, our ME services team offers superior depth of technical understanding, extensive candidate and job market reach and highly proficient contract employment screening and matching.