QMS Implementation Consultant

1 week ago

Kennesaw, United States Visionaire Partners Full time

QMS Implementation Consultant

This is a tremendous opportunity to join a progressive company delivering innovative solutions to its customers.


REQUIRED SKILLS:

  • Experience with implementations of QMS in medical device industry companies (small/medium size).
  • Experience in managing the selection of QMS systems and overseeing RFQ processes.
  • Proven track record in collaborating with cross-functional teams in multinational settings.
  • Deep knowledge of medical device regulations (FDA, ISO 13485, etc.) and quality management best practices.
  • Strong project management skills, with the ability to manage complex projects across different geographies.

RESPONSIBILITIES:

  • Drive the vendor and solution selection of a new Quality Management System (QMS) for our manufacturing sites in the US and Europe.
  • Collaborate with cross-functional teams in multinational settings.
  • Evaluate and select the most suitable QMS systems and vendors based on specific, complex business requirements that align with the global operational needs.
  • Manage the Request for Proposal (RFP) process, ensuring clear communication of requirements, comprehensive evaluation of proposals, and selection of optimal vendors and technology solutions.
  • Collaborate with key stakeholders across various departments, including Quality, IT, R&D, and Operations, to gather input and align the QMS project objectives with each department's needs and workflows.
  • Develop a detailed and achievable global project and implementation plan that accommodates each manufacturing site's specific characteristics and requirements in the US and Europe, including a detailed migration plan from the existing QMS.
  • Work closely with the QMS implementation partner to ensure the project is executed according to the agreed plan, timeline, and budget.
  • Design and deliver training programs for end-users, ensuring they are well-prepared to use the new QMS effectively.
  • Lead change management efforts to facilitate adaptation to new processes and systems.
  • Ensure that all aspects of the QMS implementation comply with relevant regulatory standards for medical devices, including FDA regulations and ISO standards.

This opportunity is a three to six-month contract position in Kennesaw, with a potential option to extend, to manage the implementation. After the first two weeks, you can telecommute up to two days a week. Some weeks, you may be in the office five days a week due to projects and meetings.


Visionaire Partners offers all full-time W2 contractors a comprehensive benefits package for the contractor, their spouses/domestic partners, and dependents. Options include 401k with up to 4% match, medical, dental, vision, life insurance, short and long-term disability, critical illness, hospital indemnity, accident coverage, and Medical and Dependent Care Flexible Spending Accounts.

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