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.