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

Salary Range: $68k - $83k CAD
* Individual placement within the salary range will be based on experience, skills, market data, and internal equity considerations

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.

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

• Lead evaluations and assessments with external international partners to determine commercial alignment and ensure regulatory/compliance
• Support preparation and execution of activities required for timely market entry and commercialized to 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

• 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 elevate QMS-related issues requiring additional oversight or cross-functional involvement
• Prepare periodic metrics and reports to support the QMS

• 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 to material and product requirements.
• Participate in design control and sustaining engineering activities to ensure quality requirements continue to be met as products evolve.

• 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.

• 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

• 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…