Staff Auditor, Quality System Compliance & Audit; Remote

Position: 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 inspections Exceptional 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 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. #J-18808-Ljbffr Apply tot his job