Senior Supplier Quality Engineer - Remote

Overview

The Senior Supplier Quality Engineer will maintain quality assurance standards adhering to regulatory requirements, ensuring products meet customer specifications while working remotely and traveling to suppliers as needed.

In Short

• Monitor quality performance of suppliers and external manufacturers.
• Implement inspection and test methods for product lines.
• Conduct process variability studies and risk analysis.
• Lead investigations of manufacturing product quality issues.
• Support documentation for validation processes.
• Collaborate with cross-functional teams to address process variability.
• Participate in PFMEA/DFMEA preparation.
• Engage in new product development activities.
• Communicate business-related issues to management.
• Travel globally for supplier assessments and audits.

Requirements

• Bachelor's Degree in Engineering or related field required.
• 3-5 years of experience in the Medical Device industry.
• Knowledge of medical device regulations (21 CFR 820, ISO 13485).
• Experience with process validations and statistical tools.
• Ability to work in a team environment with cross-functional teams.
• Experience in sampling, design of experiments, and process capability analysis preferred.

Benefits

• Remote work flexibility.
• Opportunity to travel for global supplier assessments.
• Engagement with cross-functional teams.
• Professional development in quality assurance and regulatory compliance.