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 Insulet
Apply Now
Apply Now
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 Insulet
Apply Now
Apply Now