Description

You ensure the quality, compliance, and performance of medical technologies throughout the manufacturing process and post-market lifecycle.

This role is hybrid.

Responsibilities

• Develop and implement quality plans to ensure manufacturing consistency and product conformance.
• Lead technical investigations for manufacturing issues and customer complaints to determine root cause and implement corrective/preventive actions.
• Analyze product performance data using statistical tools and risk-based methodologies to identify trends and mitigate risks.
• Conduct hands-on evaluations of customer-returned devices and manufacturing nonconformities.
• Maintain compliance with internal quality systems and global regulatory standards, including FDA and ISO 13485.

Required Skills

• 5+ years of experience in quality or engineering roles.
• Experience in a regulated industry, specifically medical device or FDA-regulated environments.
• Proficiency in root cause investigation and corrective/preventive actions (CAPA).
• Strong data analysis and risk assessment capabilities.
• Ability to manage technical projects and represent the quality function in cross-functional teams.
• Bachelor's degree in Engineering or a related technical field.

Preferred Skills

• Experience with statistical process control (SPC) tools.
• Familiarity with ISO 14971 risk management standards.

Key Skills

Education

Any Graduate