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…