Quality Engineer

About eers

EERS develops enabling hardware and software for noise management, hearing protection, audio clarity and voice intelligibility through devices that are comfortable and secure. We are expert in real-time signal processing that builds applications for augmented hearing in industrial, medical, and consumer use cases.

Our bio-mechanical skills allow us to map and address the complexity of the human ear canal to build novel comfortable, usable, and manufacturable earpieces that are acoustically efficient.

The EERS team is made up experts in audiology, acoustics, embedded software, hardware design, bio-mechanical, industrial design, and prototype assemblers capable of working on the smallest of form factors.

Our head office is located in the heart of downtown Montréal. We offer competitive salaries as well as a great team environment with a hybrid WFH model. EERS Global is an equal-opportunity employer committed to diversity.

Purpose

The Quality Engineer supports quality system activities throughout the product lifecycle, with a strong focus on new product development, design transfer, supplier quality, and production readiness. This role partners closely with Engineering, Manufacturing, Regulatory Affairs, Supply Chain, and external suppliers to ensure products are developed, validated, transferred, and manufactured in compliance with quality and regulatory requirements.

The successful candidate will play a key role in supporting documentation control, employee training, design verification activities, supplier qualification, process validation, and the successful transition of products from development into production.

Duties and responsibilities

• Support Quality Management System activities, including document control, change management, and training administration.
• Assist in the development, review, and implementation of quality procedures, work instructions, specifications, and records.
• Support Design Control activities, including design reviews, risk management, traceability, and Design Verification & Validation testing.
• Participate in Design Transfer activities to ensure successful transition of products from development into manufacturing.
• Coordinate supplier quality activities, including supplier qualification, audits, Supplier Change Notifications (SCNs), PPAPs, performance monitoring, and corrective actions.
• Investigate non-conformances, perform root cause analysis, and support CAPA implementation and effectiveness verification.
• Collaborate with Engineering, Manufacturing, Regulatory, and Supply Chain teams to resolve quality issues and support product launch readiness.
• Support process validation, inspection planning, and production readiness activities for new and existing products.
• Monitor quality metrics and contribute to continuous improvement initiatives.
• Support internal audits, external audits, and regulatory inspections while ensuring compliance with applicable quality standards and regulations.

Qualifications

• 2–5 years of experience in Quality Engineering, Supplier Quality, Manufacturing Quality, or Product Development Quality.
• Experience supporting new product development and/or design transfer activities preferred.
• Experience working within a regulated environment such as Medical Device, Pharmaceutical, Aerospace, Automotive, or similar industries.
• Experience with document control systems and training processes is considered an asset
• Experience working within ISO 13485 and FDA Quality System Regulation environments.
• Experience supporting Design Verification and Validation activities.
• Experience with supplier qualification, PPAP, process validation, and product launches.
• Medical device industry experience preferred.