Staff 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 values. Are you ready to join us?
Sterility Assurance is a speciality in the quality team in conjunction with their normal Quality Assurance or Quality Engineering responsibilities, this individual assists in carrying out tasks to support the development, and continued validation of product packaging and sterilization methods.
Snapshot of Responsibilities
- Ensure proper verification and validation of all packaging systems to all applicable regulatory requirements.
- Coordinate sterilization validations with contract sterilizers to applicable regulatory requirements.
- Conduct yearly review of sterilization validation files.
- Maintain records of production lab and product viable files.
- Assist in the troubleshooting of production packaging line issues.
- Source and recommend any new equipment required for packaging activities.
- Review all product and package changes to assess impact of packaging and sterilization verification and validation files.
- Assist in quality audits and quality investigations especially as it relates to sterilization.
- Review and ensure the adequacy of Pyrogenicity test protocols and processes.
- Assist in developing policies, standards and procedures for the engineering and technical work performed in packaging and sterilization.
- Ensure continued compliance and compliance to new packaging and sterilization standards.
- Comply with the health and safety policies of the company and inform management of unsafe working conditions.
What you bring to the team
- Bachelor's Degree in Engineering required
- Experience with statistical analysis, package design, basic microbiology and medical sterilization methods is preferred.
- Knowledge of ISO 14971, 21 CFR part 820, ISO 11135 and ISO 11607 is an asset
- 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
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.
Meet Some of Baylis Medical's Employees
Staff R&D Engineer
Linus and his team develop new medical devices, overseeing and reviewing the technical challenges involved while also communicating with other departments in order to get products to market.
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