Quality Assurance Analyst

Contribute towards safe and effective products at a fast-growing medical technology company!  Type of Position :   Full Time  Location :   Kitchener HQ – In-office presence required 4 days per week  Benefits :   RRSP with employer match, health benefits (effective day-1!), wellness benefit, learning & development opportunities, paid vacation, personal days, and sick days  The Company  Intellijoint Surgical develops effective and easy-to-use products to enhance surgeons’ care and patients’ lives.

Today, Intellijoint technology lives in the operating room, helping surgeons improve implant positioning during hip and knee replacement surgeries.

Our technology has been used in over 80,000 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.  The Position  Reporting to the Quality and Regulatory Affairs Manager, the Quality Assurance Analyst will own key Quality Management System (QMS) processes, support entry into new international markets, and work closely with internal and external partners to ensure Intellijoint products remain safe, effective, and compliant globally.  This role is ideal for someone who :   Is a detail-oriented and proactive quality professional  Thrives in a fast-paced environment, with experience in regulated industries  Enjoys cross-functional collaboration internally and working with external partners  Main Duties :   OUS Market Entry & Global Regulatory Support  Lead evaluations and assessments with external international partners to determine commercial alignment and ensure regulatory / compliance   Support the preparation and execution of activities required for timely market entry and commercialization in new international markets  Understand and apply country-specific compliance requirements, standards, and regulatory pathways.  Act as a key cross-functional liaison for OUS initiatives, ensuring alignment between Regulatory, Operations, Quality, and external stakeholders  Quality Manager System (QMS) Maintenance & Compliance  Own and manage QMS maintenance tickets, ensuring timely updates, accuracy, and compliance to applicable standards (ISO 13485, MDSAP, etc.)  Perform quality assurance activities related to audits, training, change control, document, and record management.  Identify when to escalate QMS-related issues requiring additional oversight or cross-functional involvement Prepare periodic metrics and reports to support the QMS.  Product Support & Operational Quality  Provide backup support to other QA team members for release activities, including review and approval of product inspection reports to support hardware shipments for new and existing markets.  Assist in maintaining production processes and ensuring compliance with material and product requirements.  Participate in design control and sustaining engineering activities to ensure that quality requirements are met as products evolve.  Supplier Management & Supplier Quality Activities  Manage supplier maintenance activities, including scheduling and conducting surveillance audits, maintaining supplier performance scorecards, and assessing supplier performance.  Recommend re-auditing or disqualifying suppliers when appropriate, in collaboration with Operations and R&D stakeholders.  Work closely with the QA team member responsible for SCARs to ensure appropriate corrective actions are implemented.  Support quality oversight of manufacturers and key suppliers as products evolve post-design transfer.  General Quality Assurance Responsibilities :   Analyze quality data to identify trends, risk, and opportunities for improvement.  Maintain and support the Design History File for both regulatory compliance and customer requirements  Skills and Experience to Enable Success :   3-5+ years of relevant quality management experience in a regulated industry   Knowledge of Medical Device standards (ISO 13485, MDSAP, ISO 14971, IEC 60601)  Demonstrated experience leading cross-functional projects or initiatives  Experience with OUS regulatory requirements or country-specific compliance processes is a strong asset  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  Attention to detail and appreciation for process   Why Join Us?  It is unrealistic for us to believe we will find someone who fits this position 100%  Strong support towards career development and growth  Work with innovative products that can improve surgical outcomes and enhance patient’s quality of life  Be ready to innovate!  Work alongside a highly talented and driven group of team members and colleagues organization wide  Work in an environment with high transparency and collaboration, along with lots of fun and social activities  Be ok with change and share in our excitement as we scale   Flexibility so that you can do your best both at work and outside of it  Intellijoint Surgical is committed to creating an accessible and inclusive work environment.

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.  Intellijoint Surgical encourages applications from all qualified candidates.

Those in need of accommodation at any stage in the recruitment process should notify  hr@intellijointsurgical.com .

Any information received that relates to accommodation needs of a candidate will be addressed in a confidential manner.  Powered by JazzHR