Documentation Specialist Position Available In Bergen, New Jersey

Job Description:

Title:

Quality Management Document Specialist III Pay Rate:

$34.20/hr

Location:

Franklin Lakes, NJ Note:

This is a W2 contractrole, and it is NOT open to C2C or 3rd party candidates Thisposition is responsible for converting hundreds of documents fromone template to another, including minor content changes andrevising documents for reference updates due to an organizationalchange separating one business unit into two. This position willserve as primary support for the conversion of Quality SystemProcedures and Records from the IDS business unit to the SMbusiness unit’s format and content, processing a high-volume ofMicrosoft Word documents. The Quality Management DocumentSpecialist is accountable for support of the continued development,improvement, and implementation of Quality Systems. This positionactively participates in quality guidance, product resolutiondecisions, and project teams for process improvement and continuousimprovement activities.

Job Responsibilities:

• Apply qualitysystem standards to assigned quality system area
• Developsolutions to routine assigned activities of moderate scope ∁lexity
• Follow applicable company/unit procedures and makeupdates to procedures and policies, as needed
• Work within andacross functions for assigned quality systems
• Maintain a workingknowledge of quality systems regulatory requirements and theirapplication to company/unit requirements
• Serve as primary supportfor the conversion of Quality System Procedures and Records fromIDS business unit to the SM business unit’s format and content
• Perform other duties, as required

Job Qualifications:

• 5 years ofrelevant experience, OR a combination of equivalent education andrelevant experience
• High proficiency in Microsoft Word andgeneral documentation management
• Ability to prepare or revisepolicies, procedures, and revise documents with a high degree ofaccuracy and efficiency
• Working knowledge of FDA medical devicequality system regulations and international quality systemstandards/regulations, such as 21 CFR Part 820, ISO 13485, MDSAP,EU

MDR/IVDR

• Working knowledge of applicable corporate and/or unitrequirements
• Ability to contribute to the completion of specificprograms and projects
• Ability to ensure quality conduct ofprojects, including design, data summary, interpretation, andreport generation for self and lower level project developers
• Ability to determine and develop approach to solutions, workingindependently within defined parameters and under minimalsupervision
• Ability to develop solutions to routine assignedactivities of moderate scope and complexity
• Experience withQuality Systems, such as SAP, Trackwise, or PEGA, preferred
• Aminimum of a Bachelor’s Degree in Computer Science, Engineering ora similar field; Certified Quality Auditor or Transactional SixSigma Green Belt Certification preferred