Quality Systems Manager

femtherapeutics; Montreal; Ibrido; CAD 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Comprehensive benefits

Vacation and sick days (3 weeks + 2</=

Team activities

Downtown Montreal office

Descrizione del lavoro

FemTherapeutics Inc. in Montreal, QC, seeks a Quality Systems Manager for a full-time, hybrid position with partial work-from-home flexibility.

The role focuses on maintaining a QMS throughout device development, implementing manufacturing and inspection/testing controls, and guiding design and development documentation to compliant standards. The ideal candidate has a mechanical/biomedical engineering background, 5+ years in medical devices, ISO 13485 knowledge, GDP familiarity, and strong

Competenze

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

Mansioni

• Conduct gap analyses against QMSR and ISO 13485 to identify missing specifications and drive resolution.
• Own and maintain the QMS throughout device development, including document revisions, sign-offs, and lot traceability.
• Review and strengthen Design Controls for improved specificity.
• Execute and enforce core quality processes (Manufacturing Controls, Supplier Management, Document Release) for ISO 13485 compliance.
• Define and implement manufacturing quality requirements for V&V and production (Gage R&R, IQ/OQ/PQ, DHF planning).
• Compile and maintain the Design and Development Files (DDF) and Medical Device Files (MDF).
• Collaborate with cross-functional teams to ensure compliant processes.

Conoscenze

Quality controls

Quality inspection techniques

ISO 13485 & GDP

Organizational skills

Procedures & work instructions

English proficiency

Travel flexibility Canada/USA

Formazione

Bachelor's Degree in Engineering

Descrizione del lavoro

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 afull-time, hybrid role based inMontreal, QC, with flexibility forpartial work from home. We're buildingthe first OTC pessary forpelvic organ prolapse and postpartum recovery, and are currently in V&V on the way to a 510(k), so we'relooking for a Quality Systems Manager who knows QMSR and ISO 13485 well.This role will be responsible formaintaining a QMS throughoutdevelopment, 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.