Title: Quality Management Document Specialist III

Pay Rate: $34.20/hr

Location: Franklin Lakes, NJ

Note: This is a W2 contract role, and it is NOT open to C2C or 3rd party candidates

This position is responsible for converting hundreds of documents from one template to another, including minor content changes and revising documents for reference updates due to an organizational change separating one business unit into two. This position will serve as primary support for the conversion of Quality System Procedures and Records from the IDS business unit to the SM business unit’s format and content, processing a high-volume of Microsoft Word documents.

The Quality Management Document Specialist is accountable for support of the continued development, improvement, and implementation of Quality Systems. This position actively participates in quality guidance, product resolution decisions, and project teams for process improvement and continuous improvement activities.

Job Responsibilities:

·         Apply quality system standards to assigned quality system area

·         Develop solutions to routine assigned activities of moderate scope & complexity

·         Follow applicable company/unit procedures and make updates to procedures and policies, as needed

·         Work within and across functions for assigned quality systems

·         Maintain a working knowledge of quality systems regulatory requirements and their application to company/unit requirements

·         Serve as primary support for the conversion of Quality System Procedures and Records from IDS business unit to the SM business unit’s format and content

·         Perform other duties, as required

Job Qualifications:

·         5+ years of relevant experience, OR a combination of equivalent education and relevant experience

·         High proficiency in Microsoft Word and general documentation management

·         Ability to prepare or revise policies, procedures, and revise documents with a high degree of accuracy and efficiency

·         Working knowledge of FDA medical device quality system regulations and international quality system standards/regulations, such as 21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR

·         Working knowledge of applicable corporate and/or unit requirements

·         Ability to contribute to the completion of specific programs and projects

·         Ability to ensure quality conduct of projects, including design, data summary, interpretation, and report generation for self and lower level project developers

·         Ability to determine and develop approach to solutions, working independently within defined parameters and under minimal supervision

·         Ability to develop solutions to routine assigned activities of moderate scope and complexity

·         Experience with Quality Systems, such as SAP, Trackwise, or PEGA, preferred

·         A minimum of a Bachelor's Degree in Computer Science, Engineering or a similar field; Certified Quality Auditor or Transactional Six Sigma Green Belt Certification preferred

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