Job Description

Hope everything is going well at your end!

This is SAVI from integrated resources (IRI), I am working as Delivery Lead at IRI

Quick Hiring!

Spec 3, Quality Document Sys Mgmt

Franklin Lakes, NJ

Job Type: Contract/Temporary

Duration: 12 Months+

Industry: Medical Device / Quality Systems

Pay rate: $34.20/Hr on w2

Job Summary:

We are seeking a Sr. Quality System Specialist to support the high-volume conversion of Quality System documentation due to an organizational transition—specifically separating the IDS business unit into the SM business unit. This position requires exceptional proficiency in Microsoft Word, a strong understanding of document control, and knowledge of FDA and international quality regulations. You will play a key role in revising, converting, and updating policies, procedures, and quality records with precision and efficiency.

Key Responsibilities:

Converting hundreds of documents from one template to another including minor content changes and revising other documents for reference updates due to an Organization Change separating one Business Unit into two.

Must Haves:

Serves as primary support for the conversion of Quality System Procedures and Records from IDS business unit to SM business unit format and content.

High proficiency in Microsoft Word / Document Management is required.

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

This is primarily high volume work in Microsoft Word.

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

Job Responsibilities:

• Consistent application of quality system standards to assigned quality system area.

• Develops solutions to routine assigned activities of moderate Product & complexity.

• Follows applicable Company/Unit procedures and may make updates to procedures and policies.

• Works within and across functions for assigned quality systems.

• Working knowledge of quality systems regulatory requirements and application to Company/Unit requirements.

• Serves as primary support for the conversion of Quality System Procedures and Records from IDS business unit to SM business unit format and content.

• May perform other duties as required.

Education and Experience:

• Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline and a minimum of 5 years of relevant experience or a combination of equivalent education and relevant experience.

Knowledge and Skills:

• High proficiency in Microsoft Word / Document Management is required.

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

• Working knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR).

• Working knowledge of applicable Corporate and/or Unit requirements

• Contributes to the completion of specific programs and projects.

• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.

• Can independently determine and develop approach to solutions.

• Ability to work independently within defined parameters under minimal supervision.

• Can develop solutions to routine assigned activities of moderate Product & complexity.

• Experience with Client software systems utilized in the Quality Systems is desirable.

Preferred Skills & Certifications:

o SAP, Trackwise, PEGA

• Certified Quality Auditor or Transactional Six Sigma Green Belt desirable.

Stay Safe and Stay Healthy

Thanks & Regards,

Savi Sharma

Delivery Lead (Recruitment)

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