Staff Auditor, Quality System Compliance & Audit; Remote

Employer Industry: Medical Device Company

• Salary up to $172,900
• Opportunity for incentive compensation
• Comprehensive benefits package including medical, dental, and vision insurance
• 401(k) with company match and paid time off (PTO)
• Chance to lead and influence quality improvements within a growing organization
• Work in a dynamic environment dedicated to simplifying life for people with diabetes and other conditions

• Lead planning, execution, and reporting of complex internal audits across global sites
• Develop and maintain a robust, risk-based internal audit program to identify compliance risks
• Serve as a key liaison during external audits and regulatory authority engagements
• Collaborate with internal teams to harmonize audit practices and ensure compliance
• Analyze audit data and present findings to management and regulatory bodies

• Bachelor’s degree in engineering, life sciences, or a related technical discipline; advanced degree preferred
• 8–10 years of experience in Quality Assurance or Regulatory Affairs in the medical device industry
• Extensive knowledge of ISO 13485, 21 CFR 820, EU MDR 2017/745, and MDSAP
• Strong command of audit, CAPA processes, and quality system controls
• Excellent written and verbal communication skills, with experience presenting to executive leadership

• CQA, CMDA, or equivalent active certification
• Expert user skills in the M365 Office suite including Teams and Share Point
• Experience with electronic QMS solutions and audit management tools
• Familiarity with additional international regulatory frameworks (e.g., Health Canada, TGA, PMDA)