Quality Engineer

About the role

We're looking for a Quality Engineer II who will bring rigor, flexibility, and a collaborative mindset to our Quality function. Reporting to the Quality Manager, you will own several operational pillars of our Quality Management System, helping the team move faster without sacrificing rigor or compliance.

Responsibilities

• Own day-to-day Arena administration and support ongoing improvement of Arena workflows in alignment with applicable regulations.
• Own computer software assurance (software validation) activities for software tools used in development and quality processes, including risk-based validation planning and execution.
• Administer change control activities and change implementation, partnering with Engineering subject matter experts to improve documentation quality, clarity, and accuracy.
• Perform receiving and inspection activities for incoming parts and materials, including dimensional inspection, documentation, and disposition — providing coverage and faster turnaround alongside the Quality Manager.
• Support supplier management activities, including qualification documentation, audit preparation and tracking, and supplier communications.

Qualifications

• Bachelor's degree in a technical, scientific, or engineering discipline, or equivalent practical experience.
• 2–4 years of experience in a quality, manufacturing, or related technical role.
• Experience working in electronic QMS/PLM platforms (Arena PLM preferred).
• Strong attention to detail, clear written and verbal communication, and comfort managing multiple concurrent tasks and shifting priorities in a fast-paced startup environment.

Preferred Qualifications

• Experience in regulated environments, particularly medical devices (ISO 13485) and medical device software (IEC 62304).
• Experience with computer software assurance for production and quality management system software.
• Experience with supplier quality management, incoming inspection, and/or receiving inspection processes.
• Experience with dimensional inspection and/or vision inspection systems.
• Familiarity with statistical techniques (e.g., SPC, sampling plans).