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Compliance Engineer

Company: GHG Systems
Location: Sunnyvale
Posted on: August 3, 2020

Job Description:

Roles and Responsibilities Responsibilities of this position will include, but are not limited to the following bull Provide active support, expertise, during regulatory audits and inspection, which includes practical experience directing the front andor back room. Facilitate and ensure the successful execution of certification and surveillance audits. bull Plan and execute efforts to drive regulatory audit recommendationsobservations. Ensure that responses are clear, comprehensive, accurate, and well-written to mitigate potential for further regulatory actions. bull Proactively identify and anticipate risk of non-compliance in a dynamic environment, conformance to regulatory requirements, internal processes and policies. Help track and trend data on common areas of vulnerability. bull Work with a cross functional team to lead the remediation efforts and ensure resolution. bull Provide support for continuous improvement of the audit programs, and company-wide inspection readiness. Requirements Bachelorsrsquo degree in Engineering or the Physical or Biological Sciences recommended. 5 years in a Quality, Compliance or Regulatory role in the medical device or other regulated manufacturing environment. Min. 3 years of experience managing audits, providing frontback room support Ability to understand the regulations and provide internal interpretation and practical application. Working knowledge of implementing and providing guidance on domestic and international regulations. Applied understanding of QSR (21 CFR Part 820), ISO 13485, MDSAP, EUMDR. CQECQA Certification (Preferred) Ability to be a true team player and a partner with the cross functions teams be part of the solution and demonstrate ability to use sound judgment in implementing practical Quality System and Compliance solutions. Critical thinking skills and a passion to work in a fast-paced industry with complexcutting edge technology Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment.SDL2017

Keywords: GHG Systems, Sunnyvale , Compliance Engineer, Engineering , Sunnyvale, California

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