Quality Engineer, Sterility Assurance
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 valu es. Are you ready to join us?
We are seeking an energetic engineer to join our Sterility Assurance team. This individual will work with the team to support the development and continued validation of packaging and sterilization methods.
Snapshot of Responsibilities
• Ensure that manufacturing facilities are maintained in a validated state for terminally sterilized medical device manufacturing through environmental monitoring and testing
• Implement industry standards and best practices for packaging, sterilization and facility monitoring for our products, packages and facilities
• Assist in the troubleshooting of production packaging line issues
• Review facility, product and package changes to assess impact to our products, specifically as it relates to packaging and sterilization verification and validation files
• Assist in the development and validation of packaging for our products
• Assist in the development and validation of cleaning and sterilization processes for our products
• Assist in developing policies, procedures and instruct for the engineering and technical work performed in packaging and sterilization
• Ensure continued compliance and compliance to new and revised packaging and sterilization standards
What you bring to the team
• Bachelor's Degree in Engineering required
• Excellent analytical and communication skills (both written and oral)
• Able to work independently and in a multidisciplinary team environment
• Proficient in MS Office
• Experience with statistical analysis, package design, basic microbiology and medical sterilization methods is preferred
• Knowledge of ISO 13485, ISO 14971, 21 CFR part 820, ISO 11135 and ISO 11607 is preferred
What we have to offer
- 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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