QA Analyst with Performance Testing
6 days ago
Contribute towards safe and effective products at a fast-growing medical technology company Full Time
Kitchener HQ – In office presence required 3-days per week
Today, Intellijoint technology lives in the operating room, helping surgeons improve implant positioning during hip and knee replacement surgeries. We are seeking a Quality Assurance Analyst to join our Quality Assurance & Regulatory Affairs (QA/RA) team to help bring innovative technologies to the market.
Reporting to the Quality and Regulatory Affairs Manager, the Quality Assurance Analyst will support design, production, and process quality. The QA Analyst will contribute to the maintenance of the quality management system ensuring compliance to industry standards and regulatory requirements. Initiate, compose, review, and coordinate cross-functional stakeholders to manage quality issues (e.Manage the documentation, investigation, and closure of complaints, including coordination with Regulatory Affairs to determine reportability, as required
Perform quality assurance activities related to audits, training, change control, document and record management
Prepare periodic reports to support the Quality Management System
Analyze sources of quality data to identify problem trends and opportunities for improvement
Assist in the maintenance, approval, and creation of quality documentation
Support planning and execution of design control deliverables
Maintain the content of the Design History File to regulatory and customer requirements
Participate in the development of new medical device technologies and sustaining engineering projects by providing insight into how quality requirements are met and maintained
Post-Graduate diploma in Quality Assurance is an asset
~3-5 years of relevant quality management experience in a regulated industry
~ Knowledge of Medical Device standards (ISO 13485, MDSAP, ISO 14971, IEC 60601)
~ Working knowledge of root cause analysis tools, CAPAs, Deviations, and NCRs
~ Experience working with software and/or electromechanical products
~ Familiarity with US, Canada, and International Medical Device Regulations
~ Work with innovative products that can improve surgical outcomes and enhance patient’s quality of life
Work in an environment with high transparency and collaboration, along with lots of fun and social activities
It is our policy to recruit and select applicants solely on the basis of their qualifications. We are an equal opportunity employer that hires talent regardless of age, race, creed, colour, religion, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, or any other status or condition protected by applicable law.
Those in need of accommodation at any stage in the recruitment process should notify hr@intellijointsurgical.
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