Quality Engineer, Medical Device
Baylis Medical is a leading developer, manufacturer and supplier of high-technology medical devices for cardiology, radiology and spine products. Baylis Medical products are marketed in over 65 countries. Our goal is to conceive, develop, manufacture, and sell state-of-the-art medical products that will improve the lives of people around the world. To assist us in realizing our goal, Baylis Medical adheres to four main guiding principles: Technological Leadership, Employee Development, Customer Service and Corporate Social Responsibility.
Our team is growing and we are currently looking for a Quality Engineer to join our team. As a member of the Quality department, the Quality Engineer plans, coordinates and implements QA/QC procedures and processes under direction on the Quality Manager. You will perform investigations and analyses within a well-defined scope and objectives. This individual may also provide technical guidance in areas which they are assigned.
Snapshot of Responsibilities
- Conduct investigations related to deviations and supports production and incoming inspection activities. Participate in projects as assigned
- 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 and review and approve process changes
- Help to formulate quality policies and procedures
- Provide training within the scope of objectives of the assigned work as necessary
- Participate in internal audits as an Auditor
- 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
- 1-2 year related working experience (summer internship, internship or masters) from a regulated industry such as medical device, aeronautical or pharma industries
- Knowledge of ISO 13485 or ISO 9001 and ISO 19011 required
- Training or certification in quality field is highly preferred
- 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
Baylis Medical is an equal opportunity employer and encourages applications from all qualified individuals. Please inform us if you require any accommodations during the recruitment process.
While we thank all applicants, only those being considered for an interview will be contacted.
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