Description

You will lead quality management system transformation projects, specifically transitioning from ISO 9001 to ISO 13485.

This role is on-site.

Responsibilities

• Lead projects focused on transforming and transitioning quality management systems from ISO 9001 to ISO 13485.
• Develop project plans covering timelines, resource allocation, and risk management strategies.
• Coordinate with cross-functional teams to ensure project execution aligns with strategic goals.
• Ensure compliance with ISO 13485 standards and regulatory requirements throughout the project lifecycle.
• Drive continuous improvement initiatives to enhance quality processes and systems.

Required Skills

• Proven project management experience at a systems transformation level.
• Demonstrated experience transitioning QMS from ISO 9001 to ISO 13485.
• Regulatory experience in an ISO 13485 or ISO 15378 environment.
• Strong understanding of quality management principles and best practices.
• Bachelor's degree in Quality Management, Engineering, Life Sciences, or a related field.
• Minimum 2 years of experience in quality management and project management roles within a regulated industry.
• Expertise in QMS, ISO standards, and systems transformation.

Preferred Skills

• Project Management Professional (PMP) certification or equivalent.

Key Skills

Education

Bachelor's degree