Senior Quality Systems Manager – Medical Devices (ISO 13485 / FDA)

Job summary

The role involves maintaining the Quality Management System throughout device development and implementing manufacturing and inspection controls. The manager will also oversee Design History Files and ensure compliance with ISO 13485 and QMSR standards.

Job details

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 been featured in Forbes and Fast Company, and has been named by CIX as one of the Top 20 Innovative Companies in Canada. Please read carefully before applying: this is not a software QA/engineering position. We need a Quality Management professional with hands-on medical device experience Role Description The Senior Quality Engineer 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 Engineer 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 (knowing French is an asset). 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, 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. A beautiful office environment located on Sherbrooke/Crescent right in the heart of downtown Montreal.

What you’ll do

The role involves maintaining the Quality Management System throughout device development and implementing manufacturing and inspection controls. The manager will also oversee Design History Files and ensure compliance with ISO 13485 and QMSR standards.

Requirements

Requires a Bachelor's degree in Engineering and over 5 years of experience building quality controls for Class II or higher medical devices. Proficiency in ISO 13485, GDP, and advanced English is essential.

Benefits

• Medical Coverage
• Dental Coverage
• 3 Weeks Vacation
• 2 Sick Days
• Paid Holiday Closure In December

Listed skills

• Development · Preferred
• management · Preferred
• Compliance · Preferred
• English · Preferred
• Health · Preferred
• Planning · Preferred
• Production · Preferred
• Software · Preferred
• Control · Preferred
• Documentation · Preferred
• French · Preferred
• Group Benefits · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• ISO 13485
• QMSR
• Quality Management Systems
• Medical Device Regulations
• Design History File
• V&V Planning
• IQ/OQ/PQ
• Good Documentation Practices
• Design Controls
• Supplier Management
• Gage R&R
• Medical Device Files

Job areas

• Engineering
• Healthcare
• Manufacturing
• Management & Leadership
• Science & Research