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Quality Assurance and Regulatory Affairs Manager - Mississauga, Canada - Trexo Robotics

Trexo Robotics

Verified Company

Mississauga, Canada

4 weeks ago

Posted by:

Sophia Lee

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Description

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 Manager 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 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

Oversee the development, documentation, and improvement of the quality management system (QMS) to ensure compliance with FDA CFR Part 820, ISO 13485 and other relevant regulations and standards.
Support the design development and production teams to ensure compliance with applicable medical devices regulations, standards and requirements, including risk management processes (ISO 14971), software lifecycle processes (IEC 62304), 6060
Ensure oversight of the Design History File (DHF) and Device Master Record (DMR).
Interpret regulations and standards and work with internal stakeholders to create compliant quality procedures and processes considering product risk and company size.
Conduct internal audits and work with 3rd party auditors.
Assist in preparing regulatory filings such as IDE, 510(k), CE Mark, and others.
Secure necessary Institutional Review Board approvals to maintain ethical standards for user testing and clinical trials.
Renew and manage medical device licenses and registrations.

Required Skills:

5+ years of demonstrated success in the QA/RA role for a medical device company with a product on the market.
Very good understanding of QMS for an earlystage product and new product development from ideation specification, through market launch and revenue generation, and postlaunch maintenance.
Very good understanding of medical device regulations in Canada, USA and Europe Union.
Proficient understanding of quality management systems, regulatory requirements (e.g., ISO 13485, ISO 14971, IEC 62304, FDA CFR Part 820), and quality tools/methodologies (e.g., CAPA, risk management, root cause analysis).
Experience in developing GxP SOPs and training personnel regarding those SOPs and the corresponding government regulations.
Experience in interacting with representatives from the FDA or other regulatory agencies.
Experience in managing people, internal teams, and/or contractor partners.
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 fastpaced environment.

Nice to Have