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
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