Quality Assurance Analyst

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

• 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