At Stoko, we know that life is better when we are able to do the activities we love. That’s why we’ve created the world’s first and only Supportive Apparel that’s proven to help people get active again and stay active for as long as possible. Based in Vancouver, British Columbia, we have assembled a multi-disciplinary team of dreamers, designers, and disruptors who are up for the challenge of creating a brand new consumer category and learning a thing or two along the way.

Sound like something you’d like to be a part of? Perfect, keep reading.

Start Date: August 2025

Position Overview:

What happens when a high-performance technical garment is also a medical device? As Stoko's Quality Assurance and Regulatory Affairs Lead/Senior, your challenge is to navigate the regulatory pathways and quality standards for both consumer goods and medical-grade products. But this senior-level role is about more than just compliance; it's about owning the integrity of a truly multimodal product. You will be the critical link who builds the systems and strategies that ensure our products do not fail and can withstand the rigours of the activities our users love. Through this work, you will make our Supportive Apparel synonymous with durability and reliability, bridging the gap between innovative design and robust, real-world performance.

Roles & Responsibilities:

• Integrated Quality & Integrity Leadership
  • Develop and lead a quality strategy that is woven directly into Stoko’s design process, ensuring that quality and durability are foundational inputs from initial material selection through to final product construction and performance.
  • Direct all product validation and verification activities, managing relationships with third-party labs and overseeing in-house testing for both apparel and medical device standards.
• Hybrid Quality & Regulatory System Management
  • Develop, implement, and own a single, robust Quality Management System (QMS) that meets the standards for Class I medical devices while remaining agile and relevant for technical apparel production.
  • Own the entire regulatory lifecycle for Class I medical device products, including strategy, submissions, device listing, and establishment registration, while also ensuring all technical apparel meets relevant consumer product safety standards.
  • Oversee the finished goods inspection process, managing and coordinating inspections of products from overseas manufacturers to ensure adherence to quality standards.
  • Own the post-market surveillance process, including the management of a unified complaint handling system.
  • Lead the warranty return program, focusing on root cause analysis of product failures and identifying quality trends.
  • Collaborate directly with manufacturing partners to drive continuous improvements and implement corrective actions based on trend analysis from complaint and warranty data.
• Documentation & Reporting
  • Establish and maintain comprehensive documentation, including Design History Files (DHF) and technical files for medical devices, alongside detailed product specifications and testing packages for technical apparel.
  • Prepare and present strategic reports on unified quality metrics, system performance, and team progress to senior leadership.
• Test Equipment Development and Maintenance
  • Depending on your background and experience, you may have the opportunity to build and maintain our testing equipment (please let us know if this excites you in your cover letter).
  • Design, build, test, and maintain test equipment, including tensile testers, cyclic testers, biofidelic test fixtures, and 3D printers.
  • Utilize a combination of software (MATLAB), electronics (soldering and circuit design), microcontrollers (Arduino), and mechanical engineering tools (SolidWorks & 3D printing) to build and maintain the equipment.

Qualifications & Experience:

• A degree in Mechatronics Engineering, Mechanical Engineering, Biomedical Engineering, Engineering Physics, or a related science field is required.
• Proven experience (5+ years) in a quality and regulatory role, ideally in an environment managing medical devices (specifically Class I), technical consumer goods, or apparel.
• Experience developing and managing a QMS compliant with medical device standards (Knowledge of FDA QSR, ISO 13485 is a benefit).
• Experience with textile quality, garment construction, and apparel manufacturing processes.
• Proficiency in 3D CAD software (preferably SolidWorks) and mechanical design.
• Knowledge of regulatory requirements for Class I devices in North America (FDA, Health Canada) and an understanding of general apparel safety standards.
• Experience in software programming (especially Arduino/C++ and MATLAB), and electronics.
• A P.Eng designation is considered a strong asset.
• Awesomeness.

Perks and Benefits:

We are a team that loves to laugh together, learn from each other, and take care of one another. As a full-time employee at Stoko, you will be eligible to receive a group benefits package, as well as a health spending account to cover healthcare costs such as dental, vision care, RMT and more. Additionally, Stoko offers flexible schedules, unlimited coffee, team bonding, and an environment that fosters creativity, growth, and real responsibility.

Still excited? Awesome. Send us an email at jobs@stoko.ca! Please include a resume and a cover letter explaining why you’re excited and why you’re a great fit for our team.