QA Manager

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 of 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 is an equal-opportunity employer committed to diversity.

Job Description

Reporting to the CTO, the QA Manager is responsible for establishing, maintaining, and improving the Quality Management System (QMS) so that all devices are designed, manufactured, tested, and released in compliance with applicable medical device regulations and standards. The role also ensures that quality risks are identified, controlled, and escalated appropriately across the product lifecycle, from development through post‑market. The QA Manager is additionally responsible for ensuring that ClickUp and Greenlight Guru are consistently used as the centralized system for documenting, tracking, and managing quality‑related activities, enabling operational transparency, realistic workload planning, and preservation of institutional knowledge.

Duties and Responsibilities
• Own and maintain the QMS (procedures, work instructions, records) in line with ISO 13485, FDA QMSR (21 CFR 820), and relevant regulations.
• Ensure all quality processes—document control, training records, CAPA, audits, and design controls—are captured and tracked in ClickUp/ Greenlight Guru.
• Oversee design control quality activities: design reviews, risk management, design verification/validation oversight, design change control, and design history file/technical documentation review.
• Ensure design‑related tasks, decisions, and documentation are logged in ClickUp/ Greenlight Guru to support traceability and prevent rework
• Oversee production quality: incoming/in‑process/final inspection, batch record review, product release, risk management and nonconforming product control.
• Implement ClickUp / Greenlight Guru workflows for inspection activities, deviation management, and product‑release documentation.
• Lead CAPA, deviations, complaints, and nonconformance investigations, including root cause analysis, corrective and preventive actions, and effectiveness checks.
• Maintain full audit‑ready traceability of CAPA tasks, documentation, and closure status within ClickUp.
• Manage internal and external audits, support regulatory inspections, and ensure audit findings are addressed and closed on time.
• Use ClickUp to track audit schedules, findings, remediation tasks, and evidence collection.
• Support regulatory submissions and technical documentation (e.g., 510(k), EU submissions), ensuring quality inputs and records are complete and compliant.
• Ensure ClickUp contains up‑to‑date documents, version history, and assigned responsibilities for submission‑related activities.
• Oversee supplier quality, including qualification, quality agreements, supplier changes, and supplier audits as needed.
• Maintain supplier files, audit findings, and action plans within ClickUp / Greenlight Guru.
• Define, monitor, and report quality metrics/KPIs and drive continuous improvement projects.
• Build and maintain ClickUp dashboards for real‑time visibility into quality performance and workload.
• Provide quality training and guidance to cross‑functional teams.
• Train staff on consistent ClickUp use and enforce adherence to standardized workflows.

Education
• Bachelor’s degree in engineering, life sciences, or related field.

Qualifications
• Bachelor’s degree in engineering, life sciences, or related field.
• 5+ years of quality experience in the medical device or combination‑product industry.
• Strong knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971, and relevant regulations.
• Experience with CAPA, design controls, validation, and complaint handling.
• Strong leadership, communication, and stakeholder‑management skills.

Depending on the daily tasks to be performed, working from home may be possible. However, as we often need laboratory equipment and great collaboration between the R&D teams is essential, the hardware designer must be able to come to the office with short notice if necessary.

If you are meticulous, a problem solver, and a team player, you will feel right at home. Please send your cover letter and resume to jobs@eers.ca OR submit them through our EERS Career platform.