Staff Quality Engineer
It's an exciting time to work at Baylis Medical! We are a rapidly-growing global leader in the development, manufacturing and distribution of high-tech medical devices that improve the lives of people around the world.
Baylis is based out of Mississauga, Ontario and has offices in Montreal, the United States, the United Kingdom and Germany. The addition of a new state-of-the-art Innovation Centre in Mississauga will allow us to develop new technologies in the fields of cardiology, radiology and spine, while creating hundreds of new Mississauga-based jobs.
At Baylis, we are committed to four guiding principles: technological leadership, employee development, customer service and corporate social responsibility. We are looking for talented people who share our vision and values. Are you ready to join us?
Our team is growing and we are currently looking for a Staff Quality Engineer to join our team.The Staff Quality Engineer participates in continuous improvement activities in an cross-functional engineering team and resolves issues with manufacturing processes and supplier materials for their assigned product line. They will also work closely with new product introduction teams to ensure adequate design controls are met.
Snapshot of Responsibilities
- Conduct investigations related to deviations and supports production and incoming inspection activities
- Coordinate Material Review Board activities to gain alignment and agreement on disposition, corrections and corrective actions related to non-conformances
- Participate in projects as assigned
- Review and approve research design documents, such as Design Verification/Validation Plans/Protocols, Risk Management, Design Inputs and Design Reviews
- Review and approve process design documents, such as process validation and process control; participate in manufacturing reviews, design output documents
- Review and approve outputs from manufacturing records and inspections
- Review and approve manufacturing documents such as instructions, protocols, test methods, process changes and deviations
- Review and qualify suppliers providing materials or services for product realization activities
- Provide training within the scope of objectives of the assigned work as necessary
- May give technical guidance to Quality Inspectors, or other quality staff assigned to work on common projects
- Comply with the Health & Safety policies of the company and inform management of unsafe working conditions
- Other duties as required
- Bachelor's Degree in Engineering required
- 3-6 years related working experience (summer internship, internship or masters) from a regulated industry such as medical device, aeronautical or pharma industries
- 3-6 years related working experience in manufacturing environment
- Knowledge of ISO 13485 or ISO 9001
- Excellent analytical and communication skills (written and oral)
- Excellent organization and time management skills
- Interest in biomedical or health-related industry
- Opportunity for growth
- Competitive salary and benefits
- RRSP matching
- Flexible start times
- On site gym facility
While we thank all applicants, only those being considered for an interview will be contacted.
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