Quality Project Manager

Overview

On Site
BASED ON EXPERIENCE
Full Time
Contract - W2
Contract - Independent
Contract - 7+ mo(s)

Skills

ISO 13485
ISO 15378
MEDICAL DEVICE
MEDICAL DEVICE COMPANIES
MEDICAL DEVICES
PROJECT MANAGEMENT
TRANSFORMATION
TRANSFORMATIONS
PROJECT MANAGER
QMS
QUALITY MANAGEMENT SYSTEMS
QUALITY MANAGEMENT SYSTEM
ISO 9001

Job Details

Quality Project Manager located in Oneonta, NY (Onsite).
Details for the position are as follows:
Job Description:
  • Pay Rate: $40 - 43/Hour (W2, Biweekly)
  • Seeking an experienced Quality Project Manager to lead and manage quality management system (QMS) transformation projects within our organization. The successful candidate will have a strong background in project management at a systems transformation level and extensive experience transitioning QMS from ISO 9001 to ISO 13485. This role requires a detail-oriented and proactive individual who can effectively manage complex projects and ensure compliance with regulatory standards.
  • Lead and manage projects focused on transforming and transitioning quality management systems from ISO 9001 to ISO 13485.
  • Develop comprehensive project plans, including timelines, resource allocation, and risk management strategies.
  • Coordinate and collaborate with cross-functional teams to ensure successful project execution and alignment with strategic goals.
  • Ensure compliance with ISO 13485 standards and regulatory requirements throughout the project lifecycle.
  • Conduct regular project reviews to assess progress, identify any issues or risks, and implement corrective actions as necessary.
  • Provide expertise and guidance on regulatory requirements and standards applicable to ISO 13485 environments.
  • Facilitate communication and reporting to stakeholders, ensuring transparency and alignment with project objectives.
  • Drive continuous improvement initiatives to enhance quality processes and systems.
  • Shift Schedule: Monday - Friday, 40hrs./week
Qualifications:
  • Bachelor Degree, Minimum Required
  • 2+ Years of Project Management experience in a Quality position
  • Experience supporting ISO transitions (i.e., Transitioning from ISO 9001 to ISO 13485)
  • Experience within Medical Device industry, Preferred
  • ETQ Experience, Highly Preferred
  • PMP Certification, a plus!
  • Contract to Start, conversion/extension on performance

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