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Quality Systems Specialist I

Location: Norwood, Massachusetts , US, 02062

Summary:

Supports compliance, maintenance and improvement of the global quality management system. Assists in all quality system activities. Supports development and implementation of Quality Management System (QMS) and supporting infrastructure/tools in compliance with FDA Quality System Regulation (QSR) regulations, International Standards Organization (ISO) regulations, and internal corporate requirements.

Project Details:

  • Actively participate in audit preparation efforts for the site based in Tucson, Arizona by supporting planning, gap analysis, and mitigation implementation activities required to comply with new regulations and standards.
  • Responsible for supporting generation of QMS documentation using Electronic Document Management System (EDMS). Support coordination of document and record retention program for the site in alignment with the internal corporate requirements.
  • Write and revise Quality Systems procedures, perform gap assessments and assist in driving compliance.
  • Maintain processes/procedures to ensure compliance to internal and external requirements.
  • Provide compliance support for Quality Assurance, Regulatory Affairs, R&D, and Operations to assure regulatory compliance and appropriate business planning.
  • Create and monitors CAPAs and NCRs as required.
  • Assist manager in creating measurable data for periodic reviews of Quality System.
  • Provide support to carry out the creation, review, revision, approval, release and implementation of change orders within the Document Control System.
  • Initiate change orders and other required documentation in support of the Quality system process/records compliance.
  • Provide training support in quality concepts and tools.
  • Participate in and, where necessary, drive continuous improvement of the quality processes.
  • Support review of policies and procedures to ensure compliance with government regulations and international Quality System Regulations (QSR) including International Organization for Standardization (ISO) quality system standards.
  • Create internal audit reports and corrective action plans and establishes a structure to review audit findings and ensure effective remedial measures are agreed upon, implemented, and documented.
  • Miscellaneous duties including, but not limited to, supporting communications with scientific and regulatory bodies as necessary.

Job Experience:

  • 3 years related experience in a regulated industry, 5 years preferred, preferably with Research
  • Experience in medical devices, or other regulated industry is preferred
  • Experience in Change Management, Inspection and CAPA Management is an added advantage. Exposure to internal, external, laboratory, supplier auditing programs as appropriate

Hourly Rate: 59.5-77

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