Quality Engineer II

About Epia Neuro

Epia Neuro develops neural technology systems aimed at restoring function and independence for individuals with neurological conditions. Their platform combines implantable neural interfaces, adaptive algorithms, and assistive devices to translate neural intent into actionable real-world movements. Initially focused on stroke-related motor impairments, the company is expanding to address cognitive decline and other neurological disorders, emphasizing long-term care for the aging population.

Role Overview

The Quality Engineer II will support the Quality Management System (QMS) with a blend of rigor, adaptability, and teamwork. Reporting to the Quality Manager, the engineer will lead several operational aspects of the QMS, helping accelerate processes without compromising compliance. The role suits candidates with a few years of quality or related technical experience, either deepening expertise in medical devices or transitioning from another regulated or technical field.

Company Culture and Work Ethic

• Intentional use of time with thoughtful prioritization.
• Commitment to safety for both patients and team members.
• Ownership of outcomes beyond completing tasks, maintaining the highest standards due to real patient impact.
• Embracing humility, honesty about knowledge gaps, and prioritizing accuracy over being right.

Work Location

This position is based in Alameda, California, at the company's headquarters, requiring onsite presence three days per week.

Key Responsibilities

• Manage daily administration and continual enhancement of the Arena PLM system, ensuring alignment with regulatory requirements.
• Lead computer software assurance and validation for software tools utilized in development and quality, including planning and executing risk-based validations.
• Oversee change control processes and collaborate with engineering experts to enhance documentation clarity, quality, and accuracy.
• Conduct receiving and inspection for incoming parts and materials, including dimensional checks, documentation, and disposition to support faster turnaround with the Quality Manager.
• Assist in supplier management activities such as qualification documentation, audit preparation, tracking, and communication.

Required Qualifications

• Bachelor's degree in a technical, scientific, or engineering field, or equivalent practical experience.
• Between 2 and 4 years of experience in quality, manufacturing, or a closely related technical role.
• Proficiency with electronic Quality Management System or Product Lifecycle Management platforms, preferably Arena PLM.
• Exceptional attention to detail, effective written and verbal communication, and capability to multitask and adapt to shifting priorities in a dynamic startup setting.

Preferred Qualifications

• Experience in regulated industries, specifically in medical devices (ISO 13485) and medical device software (IEC 62304).
• Background in computer software assurance related to production and quality management software.
• Expertise in supplier quality management, including incoming and receiving inspections.
• Familiarity with dimensional or vision inspection systems.
• Knowledge of statistical methods such as Statistical Process Control (SPC) and sampling plans.

Benefits and Perks

• Competitive base salary combined with equity options.
• Complete healthcare coverage for employees and their dependents.
• Generous paid vacation time.
• Paid parental leave.
• Workspace in a scenic waterfront office in Alameda with access to collaborative facilities and laboratories.