Quality Assurance Specialist

**About us**:
Trexo Robotics (Y Combinator Company) 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 a fast-growing startup with an ever-increasing backlog of orders and are looking for a highly motivated Quality Assurance Specialist to support our quality initiatives. This role involves a comprehensive approach to maintaining quality standards and ensuring adherence to regulatory requirements within the medical device and robotics industry.

Trexo's work doesn’t stop with children. 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.

This position is hybrid (3 days in the office in Mississauga.).

**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. You have a successful track record of starting up and leading a quality management system for a small to midsize company and appreciate the difference between quality requirements for different sizes of companies.

**What you'll do**
- Contribute to the development, documentation, and improvement of the quality management system (QMS) in compliance with FDA, Health Canada, EU MDR and other relevant regulations and standards.
- Interpret regulations and standards and work with internal stakeholders to create compliant quality procedures and processes considering product risk and company size.
- Design a comprehensive QMS and action plan for Trexo Robotics' manufacturing processes including product design requirement documentation, risk assessments, control, action plans, and work instructions.
- Oversee the training of the organization in QMS processes and procedures, and assist to increase compliance as needed.
- Create and revise QMS templates, SOPs, forms and documents.
- Participate in the CAPA, NCR and Complaint handling processes.
- Ensure documentation related to the DHF and DMR is reviewed and updated.

**Required Skills**:

- 1+ years of demonstrated success in a quality assurance role for a medical device company with a product on the market.
- Proficient understanding of quality management systems, regulatory requirements (e.g., ISO 13485, Health Canada and FDA regulations), and quality tools/methodologies (e.g., CAPA, risk management, root cause analysis).
- Very good understanding of standards and regulations related to the development of medical devices (including ISO 10993, ISO 14971, IEC 60601, IEC 62366, etc.).
- Experience in developing GxP SOPs and training personnel regarding those SOPs and the corresponding government regulations.
- Strong analytical skills with attention to detail and the ability to interpret data and trends.
- Excellent communication and collaboration skills to work effectively across multidisciplinary teams.
- Proven ability to prioritize tasks, meet deadlines, and adapt to changing priorities in a fast-paced environment.

**Nice to Have**
- Knowledge of EU MDR regulations and standards.

**Compensation and Benefits**:

- Competitive pay and employee stock options.
- Unlimited Vacation policy.
- Group benefits plan (in 100% covered by the company).
- Snacks in the office.
- Dog friendly office.