Quality Engineer II - Sterility Assurance
Baylis Medical
Mississauga, Ontario
5d ago

Description

Our team is growing and we are currently looking for a Quality Engineer II, Sterility Assurance to join our Design Assurance Quality team.

This individual will work with the team to support the development and continued validation of packaging and sterilization methods.

The Quality Engineer also works closely with development teams to ensure quality requirements are met.

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
  • 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
  • Represent quality function in core team of projects as assigned
  • Review and provide technical feedback on research design documents, such as Design Verification / Validation Plans / Protocols, Risk Management, Design Inputs and Design Reviews
  • Review and provide technical feedback on process design documents, such as process validation and process control; participate in manufacturing reviews, design output documents
  • Review and provide technical feedback on outputs from manufacturing records and inspections
  • Review and provide technical feedback on manufacturing documents such as instructions, protocols, test methods, process changes and deviations
  • Review and approve technical investigation, verification and validation results.
  • Independently analyze and draw conclusions on investigations / work
  • 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
  • What You Bring To The Team

  • Bachelor's Degree in Engineering required
  • Experience with ISO 13485 may be an asset
  • Excellent analytical and communication skills (written and oral)
  • Excellent organization and time management skills
  • 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
  • Interest in biomedical or health-related industry
  • 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.
  • About Us

    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.

    Want an inside look at careers and life at Baylis? View employee profiles on The Muse and follow us on Instagram Baylismedical

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