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.
Tracks data, identifies improvement projects and manages cross-functional implementations to improve the performance of the quality system and the production line.
This position requires analytical skills that would enable the Staff QE to drive continuous improvement across functions.
Provides Quality Engineering support for manufacturing.
Investigates non-conformances and implement corrective and preventive actions in place.
Review technical documents including but not limited to change orders for product, process and quality system.
Identify and devise plan for continuous improvement.
Provide technical, project level guidance to technicians, engineering assistants or junior engineering staff.
Makes decisions in an area of expertise, and where supported by precedence or clearly defined procedure.
Utilizes quality tools including Risk analysis (FMEA), applies statistical techniques including six-sigma and DOE (design of experiments), reviews and correct drawings.
Navigates government regulations including FDA requirements and guidance under 21 CFR820, ISO13485 and ISO14971.
Present technical data to groups within and outside the organization.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Conducts independent work planning.
What you bring to the team
Bachelor’s degree in engineering required.
2-4 years of relevant experience
Self-starter with the ability to quickly learn about new processes.
Excellent analytical and communication skills (written and oral).
Ability to work effectively within team and across functions.
Nice to have :
Knowledge on various engineering principles including laser welding, molding, sterilization and biocompatibility.
Certification in Problem Solving techniques.
Medical device experience; or experience in a regulated environment
What we have to offer :
Smart commute options including complimentary shuttle from Kipling Station, and subsidized transit program.
Flexible working hours that complement core business hours.
One day off for volunteering, to give back to a charitable organization of your choice.
Purposeful work that drives career development, with opportunities to learn and grow by way of on-site training, workshops, and lunch and learn sessions.
Comprehensive total rewards package, including tuition reimbursement and lifestyle and health spending account.
Well-being initiatives, including onsite gym facility and fitness classes (yoga and boot camp).
Employee-friendly work environment, with opportunity to participate in employee-led clubs, organized sports teams, video games, foosball, ping pong, etc.
At Baylis Medical, everyone works with a shared purpose : to improve the lives of people around the world. Named one of Canada’s Best Managed Companies, we are a rapidly growing leader in the development, manufacturing and commercialization of innovative medical devices in the field of cardiology.
Our focus is on providing physicians clinically-relevant tools, so that no patient goes untreated.
We are looking for talented individuals, like yourself, to join Baylis Medical and make an impact in the lives of patients.
Are you ready to join us?
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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