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 What to Expect (Job Responsibilities): 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 What is Required (Qualifications): 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 inspectionsExceptional attention to detail with the ability to manage multiple high-priority projects How to Stand Out (Preferred Qualifications): Active certification such as CQA or CMDA Expert skills in the M365 Office suite including Teams and SharePoint 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. #J-18808-Ljbffr InsuletApply Now

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