Global QA & Regulatory Analyst for Medical Devices

Intellijoint Surgical Inc.; Kitchener; On-site; CAD 68,000 - 83,000; Full time

Benefits offered by this job

Employer-matched RRSP

Health benefits

Wellness benefit

Learning & development opportunities

Paid vacation

Personal days

Sick days

Job summary

A fast-growing medical technology company in Kitchener is seeking a Quality Assurance Analyst to manage key Quality Management System processes and support regulatory compliance for innovative products. Ideal candidates should have 3-5 years of relevant experience in a regulated industry with knowledge of medical device standards. This role offers a competitive salary range of $68k - $83k CAD and benefits like employer-matched RRSP and health benefits, promoting a flexible and collaborative work environment.

Qualifications

• 3-5+ years of relevant quality management experience in a regulated industry.
• Knowledge of Medical Device standards (ISO 13485, MDSAP, etc.).
• Experience with OUS regulatory requirements is a strong asset.

Responsibilities

• Own and manage QMS maintenance tickets ensuring compliance.
• Lead evaluations with external partners for market entry.
• Analyze quality data to identify trends and opportunities for improvement.

Skills

Detail-oriented

Cross-functional collaboration

Root cause analysis

Attention to detail

Job description

A fast-growing medical technology company in Kitchener is seeking a Quality Assurance Analyst to manage key Quality Management System processes and support regulatory compliance for innovative products. Ideal candidates should have 3-5 years of relevant experience in a regulated industry with knowledge of medical device standards. This role offers a competitive salary range of $68k - $83k CAD and benefits like employer-matched RRSP and health benefits, promoting a flexible and collaborative work environment.