Quality Assurance Leader - Remote

Overview

The Quality Assurance Leader is responsible for overseeing plant QA activities, ensuring compliance with regulatory standards, and leading the quality team to drive excellence in quality operations.

In Short

• Accountable for plant QA activities and compliance with ISO13485 and EUMDR.
• Provide leadership and direction to the quality team.
• Prepare the company for audits and inspections.
• Lead the review of non-conformances and corrective actions.
• Develop and execute the plant's quality strategy.
• Maintain documentation practices in accordance with regulatory standards.
• Drive a culture of continuous improvement.
• Collaborate with manufacturing on quality plans and inspections.
• Ensure compliance with quality-related records.
• Perform additional tasks as assigned by the manager.

Requirements

• Degree in engineering or related field.
• Minimum 10 years of experience in a manufacturing environment.
• Strong knowledge of ISO 13485 and EUMDR.
• Leadership and team development skills.
• Experience with Six Sigma tools.
• Strong interpersonal and conflict resolution skills.
• Ability to align business strategies with quality objectives.
• Experience in conducting quality management reviews.
• Ability to drive quality improvement initiatives.
• Experience in regulatory compliance and audits.

Benefits

• Opportunity to work with a global leader in medical technology.
• Inclusive and growth-centered culture.
• Chance to make a difference in human health.
• Collaborative work environment.
• Professional development opportunities.
• Competitive compensation and benefits.
• Work alongside passionate leaders and colleagues.
• Contribute to innovative solutions in healthcare.
• Be part of a mission-driven organization.
• Flexible work arrangements.