Quality Engineer - Remote

Overview

The Quality Engineer is responsible for developing and managing quality assurance processes to ensure compliance with industry standards and regulations. This role promotes an understanding of quality system philosophies and drives continuous improvement within the organization.

In Short

• Manage the Quality Management System (QMS) for compliance.
• Develop and maintain quality assurance processes and procedures.
• Lead internal and external audits for regulatory inspections.
• Conduct risk assessments and collaborate on risk management strategies.
• Manage corrective and preventive action processes for product defects.
• Perform root cause analysis and implement corrective actions.
• Evaluate and monitor suppliers for quality compliance.
• Provide reports on quality metrics and performance indicators.
• Drive continuous improvement initiatives within the QMS.
• Mentor and coach others on quality principles and methodologies.

Requirements

• Bachelor’s degree in quality assurance or related field.
• 3-5 years of experience in a regulated industry.
• Experience in leading projects in fast-paced environments.
• Process Improvement experience (Six Sigma, Lean preferred).
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Proficient in quality management software.
• Attention to detail and proactive in resolving issues.
• Ability to coach and lead cross-functional teams.
• Strong understanding of quality system management.

Benefits

• Opportunity to work with top medical device manufacturers.
• Engage in a culture of continuous improvement.
• Professional development and mentorship opportunities.
• Contribute to impactful projects in the MedTech industry.