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Compliance Engineer

Company: Antora Inc
Location: Sunnyvale
Posted on: August 1, 2020

Job Description:

Primary Function of Position This position will support ISIrsquos Internal and External Audits to ensure compliance to regulatory and statutory requirements. This person will support all activities of Third Party visits and inspections (Notied Body, FDA etc.). The personnel will ensure overall Quality Management System (QMS) compliance and ensure an up-to-date understanding of applicable laws and regulations. She will demonstrate project management skills while driving the OFI (opportunity for improvement) projects and show independence in making critical decisions, and meeting agreed upon deadlines. She will display strong CAPA Experience with focus on root cause analysis, investigation, corrective preventive actions by demonstrating problem-solving, and critical thinking skills. Proper but practical interpretation of regulations and communication of those interpretations is expected to educate the organization on eective compliance systems and processes in order to meet corporate, national and international standards. Roles and Responsibilities 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 certication and surveillance audits. bull Plan and execute eorts 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 noncompliance 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 eorts 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 Certication (Preferred)

Keywords: Antora Inc, Sunnyvale , Compliance Engineer, Other , Sunnyvale, California

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