Staff Quality Engineer - Remote

Overview

The Staff Quality Engineer is responsible for supporting reagent new product development and sustaining activities through quality engineering skills for medical devices, ensuring compliance with quality standards and regulatory requirements.

In Short

• Accountable for quality assurance in new product development and sustaining engineering for IVD products.
• Involved in process validation, risk assessment, and supplier management.
• Acts as a project lead for process improvement initiatives.
• Mentors junior team members in quality engineering practices.
• Ensures compliance with applicable regulations and corporate quality policies.
• Prepares reports and conducts audits.
• Collaborates with various teams to improve operational processes.
• Utilizes statistical tools for quality analysis.
• Maintains strong working relationships across operations.
• Participates in continuous improvement projects.

Requirements

• Bachelor’s Degree in biological science or engineering.
• Minimum of 10 years of relevant experience in quality engineering.
• Knowledge of ISO 9001, ISO 13485, ISO 14971, and cleanroom validation.
• Expertise in statistics and quality engineering principles.
• Proficiency in Minitab and MS Office.
• Strong communication skills.
• Experience with Class II/III medical devices is preferred.

Benefits

• Competitive salary and benefits package.
• Opportunities for professional development.
• Supportive work environment that encourages growth.
• Flexible work-life balance.
• Commitment to diversity and inclusion.