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Sterility Assurance

Job Title: Sterility Assurance
Contract Type: Permanent
Location: Canada
REF: 97038
Job Published: 4 months ago

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

Sterility Assurance
Our client, a medical device company in Canada is currently looking to recruit a Sterility Assurance for their site.

Role Summary

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.

  • 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

For further information on this Sterility Assurance role in Canada please contact Bimi on 086 8395531 /

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