Senior Quality Engineer - Remote

Overview

The Senior Quality Engineer will be expected to contribute to maintaining the Quality Management System of Labs 2.0 with an emphasis in Complaints and CAPA’s.

In Short

• Implement and maintain the Quality Management System.
• Integrate Analysis activities regarding product improvements, audits, and new product development.
• Track, document, and coordinate activities within Quality.
• Implement processes for complaints to ensure compliance.
• Participate and lead Risk Analysis initiatives.
• Remediate the CAPA process for compliance.
• Document processes and procedures as required.
• Perform Internal Audits.
• Support External Audits (FDA, MDSAP, ISO).
• Coordinate interactions between Quality, Engineering, Product Support, and Regulatory.

Requirements

• BS in scientific discipline preferred.
• Minimum 5 years of Quality Engineering experience.
• Good understanding of US federal regulations.
• Startup experience preferred.
• Experience using quality management systems software preferred.
• Strong English Language skills.
• Strong computer literacy required.
• Strong technical writing and communication skills.
• Ability to apply Good Documentation Practice.
• Experience with Quality tools.

Benefits

• Medical, dental, and vision plans.
• Stock options and 401(k) match program.
• Company-wide holidays and winter break.
• Self-managed PTO policy.
• Wellness and home office stipends.
• Learning & development stipends.
• Parental leave benefits.