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Added 10 mins ago
ML
Project Manager
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- Full-time
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femtherapeutics

Quality Systems Manager

Montreal, QC, Canada

Full-time

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Applications open in a new tab.

Job details

Job type: Full-time
Apply by: Apr 28, 2027
Posting language: English
Posted: Oct 30, 2026

Original job description

Company Description

femtherapeutics is transforming access to pelvic health by creating a better entry point for people experiencing pelvic conditions. The company’s flagship product is world's first home-use pessary for pelvic organ prolapse and postpartum recovery, designed for self-management without a prescription or clinic visit. This device is delivered alongside a digital platform that supports clinical screening, education, and care navigation. Through this combination of hardware and software, femtherapeutics provides direct access to screening and treatment across pelvic health needs from postpartum through postmenopause. femtherapeutics has raised over $7M+ from venture capital and institutional funds, been featured in Forbes and Fast Company, and has been named by CIX as one of the Top 20 Innovative Companies in Canada.

Role Description

The Quality Systems Manager is a full-time, hybrid role based in Montreal, QC, with flexibility for partial work from home. We're building the first OTC pessary for pelvic organ prolapse and postpartum recovery, and are currently in V&V on the way to a 510(k), so we're looking for a Quality Systems Manager who knows QMSR and ISO 13485 well. This role will be responsible for maintaining a QMS throughout development, implementing manufacturing and inspection/testing controls, supplier agreement specifications, and internal SOPs. The role further involves advising on manufacturing quality requirements for V&V and production, including equipment IQ/OQ/PQ, and Design History File (DHF) planning, as well as compiling the Design and Development Files (DDF) and Medical Device Files (MDF). The ideal candidate brings hands-on experience maintaining a quality system through active development and the ability to guide a team in applying compliant processes.

Qualifications

Bachelor's Degree in Engineering (Mechanical, Biomedical, or related field).
5+ years of building quality controls in medical devices (Class II or higher devices is preferred).
Knowledge of quality inspection techniques, including visual, dimensional, and functional inspections.
Understanding of ISO 13485 and Good Documentation Practices (GDP).
Excellent organizational skills with the ability to maintain accurate and complete records.
Ability to follow detailed procedures and work instructions with a high degree of accuracy.
Advanced English proficiency.
Ability to travel within Canada and the US occasionally to conduct site visits with contract manufacturers.

Job Responsibilities

Conduct gap analyses against QMSR and ISO 13485 to identify missing specifications and process requirements, and drive them to resolution (e.g., Product Realization Plan per ISO 13485 §7.1, Manufacturing and Inspection/Testing Controls, Supplier Agreement Specifications).
Own and maintain the QMS throughout device development, including document revisions, sign-offs, document linking and tracing for V&V planning, device revision control, and lot traceability.
Review and strengthen Design Controls for improved specificity.
Execute and enforce core quality processes (e.g., Manufacturing Controls, Supplier Management, Document Release) to ensure compliance with ISO 13485, internal SOPs, and project-specific plans such as the Quality Plan (Project Realization Plan), Project Development Plan, and V&V Plan.
Define and implement manufacturing quality requirements for V&V and production, including Gage R&R, equipment IQ/OQ/PQ, and Design History File (DHF) planning.
Compile and maintain the Design and Development Files (DDF) and Medical Device Files (MDF).

At fem, we value our employees and offer a comprehensive benefits package:

Comprehensive group benefits including medical and dental coverage.
3 weeks of vacation (+ 2 Sick Days) + Paid holiday closure in December so you can fully enjoy the festive season.
Quarterly team activities and social events to foster a collaborative and fun work environment.
A beautiful office environment located on Sherbrooke/Crescent right in the heart of downtown Montreal.

How to Apply

Please submit your CV to Negin Ashouri, Co-Founder & CTO, by email at negin.ashouri@femtherapeutics.com. Please include "Quality Systems Manager – Medical Devices (ISO 13485 / FDA) - Application" in the subject line. Apply by Monday November 9, 5pm ET.

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More about this job

Responsibilities

Maintain and improve the quality management system throughout device development, including document control, traceability, supplier management, manufacturing controls, and compliance with QMSR and ISO 13485. Define quality requirements for verification and validation and production, and compile and maintain the Design and Development Files and Medical Device Files.

Requirements

Requires a bachelor's degree in engineering and at least five years of experience building quality controls for medical devices; experience with Class II or higher devices is preferred. Candidates should know ISO 13485 and Good Documentation Practices, understand inspection techniques, maintain accurate records, have advanced English proficiency, and be able to travel occasionally within Canada and the United States.

Skills

Quality Management Systems
QMSR
ISO 13485
Medical Device Quality Controls
Quality Inspection
Visual Inspection
Dimensional Inspection
Functional Inspection
Good Documentation Practices
Gap Analysis
Supplier Management
Document Control
Design Controls
Gage R&R
Equipment IQ/OQ/PQ
Design History File Management

Benefits

Medical Coverage
Dental Coverage
Three Weeks Of Vacation
Two Sick Days
Paid December Holiday Closure
Quarterly Team Activities And Social Events

Visa sponsorship

Not detected in the job text

Hiring contact

Negin Ashouri

Hiring contact email

negin.ashouri@femtherapeutics.com

Keywords

QMSR
ISO 13485
Quality Management System
Medical Devices
Class II Devices
Verification And Validation
Product Realization Plan
Manufacturing Controls
Inspection And Testing Controls
Supplier Agreements
Supplier Management
Document Control
Document Release
Design Controls
Good Documentation Practices
Visual Inspection
Dimensional Inspection
Functional Inspection
Gage R&R
Equipment IQ/OQ/PQ
Design History File
Design And Development Files
Medical Device Files
Lot Traceability
Device Revision Control
Quality Plan
Project Development Plan
V&V Plan
Contract Manufacturers

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