At O2 Industries, we're shaping the future of personal protective equipment. Our innovative respirators protect from harmful particles, giving people the tools to unlock their potential in the most sensitive breathing situations.
We are looking for a Quality Manager to join our team. In this critical role, you will be the owner of all quality related processes and procedures and will be responsible for managing O2’s Quality Management System. You will play an important role driving initiatives to achieve various certifications, both across O2 operations and specific to our respiratory protection devices.
What You’ll Do in This Role
- Oversee O2’s Quality Management Program including creating and updating required documentation and standard operating procedures and ensuring our system, Greenlight Guru, is always up-to-date
- Understand quality compliance requirements of various governing bodies (e.g. Health Canada, ISO) and create and execute action plans to meet and maintain these standards
- Work cross-functionally to ensure quality standards are understood and met by each team, specifically with the Product Development team to facilitate design control and risk management activities and produce applicable documentation
- Understand processes to achieve product certification and work with internal and external stakeholders to complete certification requirements
- Coordinate internal and external quality audits and take ownership for subsequent action items
- Work with Product Development and Marketing teams to ensure certification timelines milestones are integrated into product development and launch plans
- Provide training to internal stakeholders as needed as part of O2’s Quality Management Program
What You Bring to This Role
- Bachelor’s degree or higher preferred
- At least 3 years of quality management experience in a regulated environment, ideally with medical devices
- Solid understanding of relevant quality standards including ISO 13485 and 9001 with familiarity of medical device quality requirements and certifications an asset
- Experience developing quality plans and documentation and providing training to internal stakeholders on how to ensure quality compliance
- Proven experience working with regulatory bodies to successfully navigate certification processes and requirements
- Strong project management capability including experience understanding, analyzing, and managing multiple inputs into quality and compliance initiatives
- Exceptional critical thinking and problem-solving capabilities with a keen desire to try new things and work collaboratively to innovate
- Excellent verbal and written communication skills with the ability to effectively convey technical information to a variety of internal and external audiences
What We Need from You
When applying, please provide your current CV or resume.
We embrace diversity and are committed to creating an inclusive workplace. We welcome applications from all qualified persons. In accordance with the Ontario Human Rights Codes, Accessibility for Ontarians with Disabilities Act (AODA) if you need accommodation at any point throughout the hiring process, please let us know.
**No agencies please**