Quality Lead

1 week ago

Mississauga, Canada Trexo Robotics Full time

**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 highly motivated Quality Lead 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.

This position is hybrid (3 days in the office) following initial onboarding.

**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**:

- Lead, manage, and continuously improve and oversee 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. Proactively recommend and implement improvements when required.
- Interpret regulations and standards and work with internal stakeholders to create compliant quality procedures and processes considering product risk and company size.
- Ensure QMS processes are effectively implemented and followed across all departments. Mentor and support staff in ensuring adherence to quality practices.
- Oversee the training of the organization in QMS processes and procedures, and assist to increase compliance as needed.
- Create, revise and update QMS templates, SOPs, forms and documents.
- Oversee projects and manage the processes for Change control, CAPA, NCR, PMS, and complaint handling, among others. This includes maintaining accurate and up-to-date records.
- Ensure documentation related to the DHF and DMR is reviewed and updated.
- Coordinate and lead internal and external audits.
- Participate in risk management activities including risk assessment, FMEA, and other risk control processes in product development and manufacturing.
- Ensure that all product quality criteria are clearly defined and met through inspection and testing.
- Develop and implement quality control processes and procedures to monitor product quality throughout the manufacturing process.
- Serve as a main point of contact and collaborate closely with the engineering, supply chain, business operations, and manufacturing teams on any questions related to quality assurance.
- Provide regular reports to management on QMS performance, audit results, compliance status, and corrective actions.

**Required Skills/Experience**:

- Education: Bachelor’s degree in Engineering, Life sciences or related field (Master’s degree preferred)
- 5+ years of demonstrated success in a quality related role for a medical device company with a product on the market.
- Certification in Quality (eg. CQE, CQA, Six Sigma) preferred.
- 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 knowledge of quality management systems and tools (e.g., CAPA, document control, internal audits).
- 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.

**Compensation and Benefits**:

- Competitive pay and employee stock options.
- Unlimited Vacation policy.
- Group benefits plan.
- Snacks in the office.
- Dog friendly office.

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