About us
Trexo Robotics is enabling mobility by building powered wearable robots. Our first product is a robot for children with movement disorders such as Cerebral Palsy, and it allows kids to walk, in many cases, for the first time in their lives. The device is currently being used by hundreds of families and the best hospitals across North America.
We are constantly working towards building mobility solutions for all. At Trexo Robotics, you will find a flat organization where you can work with highly optimistic, low ego, and exceptionally talented individuals who look forward to solving hard problems.
About the job
We are looking for a detail-oriented and motivated Senior Quality Assurance Specialist to join our Quality team and help scale and maintain our quality systems. This role is critical to ensuring our processes remain compliant with regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485:2016, EU MDR) as we grow. You will work cross-functionally with engineering, clinical, production, marketing, operations, and regulatory teams to support quality across the entire product lifecycle.
This position is hybrid (3 days in our Mississauga office).
About you
You want to work in a small team solving a big problem. You are passionate about designing and building products. You are excited by the prospect of revolutionizing multiple industries. You can juggle many tasks simultaneously. You are detail-oriented and love asking why many times till you understand something from first principles.
Ideally you have a strong background in hardware and software medical devices, process improvement, and risk management, and thrives in a fast-paced, regulated environment.
What you'll do
Maintain and improve the QMS in compliance with ISO 13485, 21 Part 820, MDR, and other applicable regulations.
Support internal and external audits, including audit readiness, documentation, and follow-up actions.
Support and/or lead quality system processes such as change control, NCRs, equipment qualification, audit preparation, post-market surveillance, and training.
Lead or support root cause investigations, risk assessments, and implementing commensurate actions related to quality issues.
Participate in product lifecycle quality activities including design control, verification/validation, and product release.
Review and approve engineering change notices, document change orders, and other change control activities to ensure compliance to applicable regulations and standards
Collaborate with cross-functional teams (Product Development, Manufacturing and Production, Supply Chain, Accounts) to facilitate and support process changes.
Analyze quality data, monitor quality metrics and support quality trending and reporting initiatives.
Provide guidance and mentoring to foster a company-wide culture of quality.
Act as a key liaison between quality and other departments to ensure compliance and best practices are embedded across the organization.
May assist with QC activities (product/component inspections, reviewing DHRs, investigate product quality issues and recommending corrective/preventative actions).
Perform other miscellaneous duties as required.
Required Skills (Mandatory)
Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
3-6 years of experience in Quality Assurance within the medical device industry, preferably in a start up or fast-paced environment.
In-depth knowledge of quality system regulations and standards (21 CFR Part 820, ISO 13485:2016, ISO 14971:2019, EU MDR, etc.)
Excellent documentation skills and attention to detail
Experience with maintaining and reporting on a quality process in day-to-day work.
Strong problem-solving, organizational, and communication skills.
Proficient in Google Drive, Microsoft Office, and general workplace applications.
Ability to work well both independently and cross-functionally.
Preferred Qualifications (Nice to Have)
Experience in a start up or early-stage medical device environment.
Certification in quality (e.g., CQE, CQA, lead auditor or similar) and background in auditing, inspections, or quality control is a plus.
Experience supporting or hosting FDA inspections or ISO audits.
Experience with system automation.
Experience with Airtable and Zapier is a strong plus.
Experience with leading quality process development and improvement initiatives.
Compensation and Benefits
Competitive pay and employee stock options.
Unlimited Vacation policy.
Group benefits plan (100% covered by the company).
Snacks in the office.
Dog friendly office.
Please note that at this time, we can only consider applicants who are already eligible to work in Canada and we are unable to provide relocation support. We appreciate your understanding and look forward to receiving your application.