Quality Lead

2 weeks ago

Mississauga, Canada Trexo Robotics Full time

**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 and experienced Quality Associate to lead our quality initiatives. As part of the small team, you will own our Quality System Management. 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 could be fully in-person or **hybrid **(3 days in the 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. 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, and other relevant regulations and standards.
- Planning, analyses (HA, DFMEA, FTA, Risk/Benefit), and mitigations - Main risk management file.
- 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.
- Conduct internal audits based on the internal audit SOP. Perform review of audit outcomes, share trends and findings, and recommend action items.
- Support QMS regulator agency inspection readiness, assist during inspections and external audits
- Develop and review of DHF documentation, including Validation and Verification plans and reports.
- Design, review and approve IQ, OQ, PQ procedures for equipment and manufacturing processes.
- Renew and manage medical device licenses and registrations.

**Required Skills**:

- 5+ years of demonstrated success in a quality assurance role for a medical device company with a product on the market.
- Very good understanding of QMS for an early-stage product and new product development from ideation specification, through market launch and revenue generation, and post-launch maintenance.
- Experience in developing GxP SOPs and training personnel regarding those SOPs and the corresponding government regulations.
- Proficient understanding of quality management systems, regulatory requirements (e.g., ISO 13485, FDA regulations), and quality tools/methodologies (e.g., CAPA, risk management, root cause analysis).
- 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**
- Applied experience in business process techniques, including but not limited to LEAN and SIX SIGMA methodologies, to improve existing workflows.
- 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.

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