Senior Quality Compliance Specialist

1970-01-01Davis Companieshttp://www.daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svg325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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Senior Quality Compliance Specialist

  • Specialty:

    Manufacturing
    • City:

      Cordova
    • State:

      TN
    • 38016
  • Assignment Type:

    Contract To Hire
  • Job Id:

    48943
  • Payrate:

    $40.00

Description

Senior Quality Compliance Specialist:

Responsibilities:

 

  • Assess complaints (root cause analysis) and determine if an investigation is required and document rationale if investigation is not required.
  • Execute timely analysis and reporting of adverse events and complete communication within the global regulatory time frames.  Also monitor, trends and track the timeliness of investigations and closure.
  • Communicate directly with national and international competent authorities on complaint/AE related questions (examples: FDA, Health Canada, BfArM, TGA, MHRA, MHLW, etc.)
  • Communicate directly with notified body, internal/external customers, distributors, physicians, suppliers and manufacturers to ensure timely completion of activities related to complaint and failure investigations.
  • Analyze information obtained during complaint investigations and prioritize complaint investigations to ensure that they are processed in a timely manner.
  • Conduct meetings, track action items and prepare documents related to complaints, vigilance, health hazard evaluations, CAPA, post-market surveillance and recalls.
  • Generate and review data and documents for compliance with U.S. and international regulations and requirements (ISO 13485, 14971, etc.).
  • Ensure that Company’s records, procedures, specifications, policies etc. comply with Federal, international and corporate standards, or other external regulations and requirements
  • Create documentation and train departmental and corporate personnel on the complaint handling, adverse event/vigilance reporting requirements and monitor compliance.
  • Responsible for staying current on international regulations and incorporating any revision or changes needed into SOP’s, work instructions, etc.

Requirements:

  • Bachelor degree in biology, health sciences, engineering, nursing or other related discipline.
  • Must have a broad understanding of regulatory and compliance issues that drive the medical device industry, including those outside of the area of his/her expertise. 
  • Should have knowledge of quality system regulations, MDR reporting system and adverse event processes.
  • Must possess good verbal and written communication skills with an investigative mindset and critical analysis skills.
  • Working knowledge of Microsoft Office software (Word, Excel, PowerPoint, Outlook).
  • Minimum 3 years’ direct experience in adverse event/MDR compliance role.
  • Must have previous experience in complaint handling and adverse event reporting.
  • Experience working with a database is preferred

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Quick Apply

  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
  • Accepted file types: pdf, doc, docx, txt, rtf.
  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

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