QMS Specialist - (NO C2C OR THIRD PARTY)

• Location: Mahwah, New Jersey (07430)
  

• Duration: 12+ month contract until 11/2025 (contract extension potential OR internal hire possibilities)
  

• Type: W2 contract (NO C2C OR THIRD PARTY)
  

• Pay: Negotiable depending on direct-related experience
  

• Work Authorization: Must be currently in the United States with active employment authorization documents.

This is an individual contributor role. Primarily responsible for facilitating document and product related changes in accordance with company’s change management procedures and relevant regulatory requirements for medical devices.

Duties Include but not limited to:

• Facilitate the change management process for document and product related changes.
  

• Perform administrative activities related to learning management system.
  

• Assist with the migration of QMS related documentation from local document management systems to PLM system (Windchill).
  

• Ensure QMS documentation reflects actual business activities while remaining compliant with applicable internal and external regulatory requirements including but not limited to Site, Division, Corporate, FDA, ISO, MDD, MDR and individual country requirements.
  

• Drive Good Manufacturing Practices and Good Documentation Practices.
  

• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS and associated documentation.
  

• Develop and deliver training for QMS areas of expertise.
  

• Engage the IT team in relevant PLM system discussions.

Required:

• BS in a science, engineering, business or related discipline.
  

• Minimum of 3 years experience in a regulated industry using electronic document/change management systems preferred.
  

• Thorough knowledge and understanding of US and International Medical Device Regulations.
  

• Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
  

• Ability to plan, organize, and implement multiple concurrent tasks.
  

• Strong interpersonal skills, written, oral communication and negotiations skills.
  

• Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
  

• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
  

• Demonstrated ability to work in cross-functional team environments.
  

• Basic understanding of compliance risk situations.

Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.

*** (Kelly does not expense relocation/interview costs)**

Work Authorization: Must be able to work in the United States with current employment authorization documents.

In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:

• Competitive pay
  

• Paid holidays
  

• Year-end bonus program
  

• Recognition and incentive programs
  

• Access to continuing education via the Kelly Learning Center

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