Quality Project Manager

Description:

US Tech Solutions is seeking an experienced Quality Project Manager to lead and manage quality management system (QMS) transformation projects. This role focuses on transitioning QMS from ISO 9001 to ISO 13485, requiring a proactive and detail-oriented individual with a solid background in systems transformation and project management.

Responsibilities:

• Lead QMS Transition: Manage projects focused on transitioning from ISO 9001 to ISO 13485, ensuring compliance with applicable standards.

• Project Planning: Develop comprehensive project plans, including timelines, resource allocation, and risk management strategies.

• Cross-functional Collaboration: Coordinate and collaborate with various teams to ensure successful execution and alignment with strategic goals.

• Compliance: Ensure adherence to ISO 13485 standards and regulatory requirements throughout the project lifecycle.

• Regular Project Reviews: Conduct regular reviews to assess progress, identify issues, and implement corrective actions.

• Expert Guidance: Provide expertise on regulatory requirements and standards relevant to ISO 13485 environments.

• Communication & Reporting: Facilitate communication with stakeholders, ensuring alignment with project objectives.

• Continuous Improvement: Lead initiatives to enhance quality processes and systems.

Experience:

• Proven experience in project management at a systems transformation level.

• Demonstrated experience in transitioning QMS from ISO 9001 to ISO 13485.

• Regulatory experience in ISO 13485 or ISO 15378 environments.

• PMP certification or equivalent is a plus.

Skills:

• Strong understanding of quality management principles and best practices.

• Excellent leadership, communication, and interpersonal skills.

• Ability to manage multiple projects in a fast-paced environment.

• Strong problem-solving skills and attention to detail.

Education:

• Bachelor's degree in Quality Management, Engineering, Life Sciences, or a related field.

Duration: 7-month contract with potential extension.