Supplier Quality Engineer - Remote

Overview

Frida is looking for a Supplier Quality Engineer to join our Operations team to take the lead in managing our critical supplier relationships and ensuring the quality and compliance of all our products.

In Short

• Lead the qualification process for new suppliers and conduct audits.
• Develop and maintain the Approved Supplier List (ASL).
• Collaborate with procurement and R&D for compliance.
• Plan and execute supplier audits in compliance with FDA and ISO standards.
• Investigate quality issues and implement process improvements.
• Ensure supplier documentation meets regulatory requirements.
• Work cross-functionally with Operations, Engineering, and Procurement teams.
• Participate in Design Review meetings for supplier capabilities.
• Support complaint investigations related to supplier components.
• Willingness to travel approximately 20-30% for audits.

Requirements

• Bachelor's degree in Engineering, Quality, or related field.
• 4+ years of experience in supplier quality within the medical device industry.
• Thorough knowledge of FDA regulations and ISO 13485.
• Certified quality professional (CQE, CQA, or equivalent) preferred.
• Experience with risk management methodologies and statistical process control.
• Strong auditing skills to identify and resolve quality issues.
• Excellent verbal communication skills.
• Working knowledge of Microsoft Office and documentation control software.
• Willingness to travel for supplier audits.

Benefits

• Robust health benefits including medical, vision, and dental plans.
• 401k matching up to 4% with immediate vesting.
• Generous paid time off program.
• Flexible paid pregnancy and parental leave.
• Weekly wellness programming.
• Dog friendly office.
• Learning & development opportunities.
• Company-wide events & outings.
• Exclusive employee product discounts.