Staff Auditor, Quality System Compliance & Audit; Remote

Employer Industry: Medical Device Manufacturing Why consider this job opportunity:

• Salary up to $172,900
• Opportunity for incentive compensation
• Comprehensive benefits package, including medical, dental, and vision insurance
• 401(k) plan with company match
• Paid time off (PTO) and additional employee wellness programs
• Work in a dynamic and innovative environment focused on improving the lives of individuals with diabetes

• Lead planning, execution, and reporting of complex internal audits across global sites in accordance with applicable regulations and standards
• 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 global teams to harmonize audit practices and ensure compliance
• Design and facilitate training programs to enhance understanding of quality system requirements

• 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
• Proven ability to lead internal audits and manage external regulatory inspections
  
  Exceptional attention to detail with the ability to manage multiple high-priority projects

• Active certification such as CQA or CMDA
• Expert skills in the M365 Office suite including Teams and Share Point
• Experience with electronic QMS solutions and audit management tools
• Familiarity with international regulatory frameworks (e.g., Health Canada, TGA)
• Experience with PLM tools such as Agile and/or Arena

We prioritize candidate privacy and champion equal‑opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.