Engineering Quality Specialist

 

Description:

The Engineering Quality Specialist, Product Development is a unique position within the QARA department at Intellijoint Surgical (IJS). This role will represent the internal QMS during product development initiatives. The successful candidate will guide the organization’s cross-functional development teams through the internal and external QA requirements. This position will be at the centre of innovation at IJS, representing the QARA team while playing a key role in ensuring fast, safe, and effective development initiatives.

As a snapshot, we are looking for someone who:

  • Will be present at every step of the design generation of Intellijoint Surgical’s innovative products; providing QA expertise and guidance to our internal product development teams
  • Will support the quality system by ensuring compliance and enforcement of regulations, standards, policies, operating procedures, and instructions related to design control

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Main Duties: *

  • Represent the QARA department in cross-functional initiatives including: product portfolios, new product development and product change projects.
  • Support multiple product line portfolios.
  • Develop and/or manage project quality plans.
  • Lead and/or participate in the translation of voice-of-quality into development requirements.
  • Define statistical sampling and testing methods required for verification and validation testing and provide measurement analysis support as required.
  • Lead and/or support the creation of development documentation.
  • Support development team in the creation, review, and approval of: engineering requirements & specifications, critical-to-quality specifications, engineering test protocols and reports required for design verification, design validation, and process validation.
  • Ensure accuracy and completeness of the Design History File and the Device Master Record.
  • Provide Post Market Surveillance complaint investigation technical support.
  • Provide guidance to team members within the Quality Assurance and Regulatory Affairs team.

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Skills and Experience to Enable Success: *

  • Degree in Engineering, a related science or equivalent experience; P. Eng. is an asset
  • 7 years of experience in a regulated industry or a scientific engineering design environment.
  • Experience in medical device development or a similarly regulated hardware/software industry is a highly desirable asset.
  • Proven experience with the tools and techniques required to apply design generation to products in development and post-launch.
  • Understanding of current medical device development standards (i.e., BS EN ISO 14971, PD ISO/TR 13485 BS EN IEC 60812)
  • Knowledge of FDA and MDR requirements for the application of Risk Management to medical device design is highly desirable.
  • Experience using Atlassian products is an asset.
  • Experience working in an agile environment is an asset.

Organization Intellijoint Surgical
Industry Engineering Jobs
Occupational Category Engineering Quality Specialist
Job Location Toronto,Canada
Shift Type Morning
Job Type Full Time
Gender No Preference
Career Level Experienced Professional
Experience 7 Years
Posted at 2022-09-03 4:34 pm
Expires on Expired