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$70 USD / hour
Flag of JAPAN
kobe, japan
$70 USD / hour
It's currently 8:59 PM here
Joined November 6, 2023
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Dmitry A.

@HamaBe083

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$70 USD / hour
Flag of JAPAN
kobe, japan
$70 USD / hour
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Quality Compliance

With two decades of experience in product compliance, quality assurance, and strategic management within global and private sectors, I offer a comprehensive skill set tailored to the medical device, household, and automation industries. My expertise extends to crisis management, corporate transformations, and M&A activities. As a compliance lead, I have overseen legal, sanctions-related, and internal audit matters, and have been responsible for P&L, sales, legal, and real estate control, among others. My practical knowledge spans across various functions, including facility and construction management, logistics, HR, tax, and IT. I have set up quality management systems, navigated legal and market access complexities, and developed global teams, particularly in product safety compliance for the Eurasian region. I have successfully increased regional turnover threefold in three years, developed and implemented competitive strategies, and created unique selling points for my region. My skills in corporate relationships, team development, top management negotiations, and delegation of responsibilities have been instrumental in these achievements. At TÜV, my role as an audit overseer has been pivotal in ensuring product sustainability through the entire development process, from management interviews to certification supervision. My proficiency in international standards like ISO13485, ISO9001, and MDR is well-demonstrated, along with my technical file reviews and key account management in Japan and Asia Pacific. My career milestones include enhancing audit efficiency, leading M&A due diligence, and significantly advancing medical device compliance. As a Project Engineer, I ensured safety compliance across various medical equipment, expanded local teams, and participated in significant compliance and certification schemes. My contributions have been integral in expanding the scope and accreditation of medical testing facilities and services.

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IRCA9001 auditor

IRCA
2011
IRCA qualified auditor

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