Lead Auditor- MED in Schaumburg, Illinois at DQS Inc.

JOB OBJECTIVES:

Perform regulatory audits and assess quality documents and/or records in accordance with the following standards and regulations: ISO 13485, MDSAP, MDD 93/42/EEC and Regulation (EU) 2017/745.

ESSENTIAL FUNCTIONS:

• Conducting audits of medical device manufacturers and their subcontractors in accordance with regulatory requirements, such as Directive 93/42/EEC, (EU) 2017/745 (MDR), MDSAP; recognized standards such as ISO 13485, including the necessary preparation, follow-ups, and reporting to support certification decision
• Performing unannounced audits, special audits, for-cause audits, etc. in accordance with regulatory requirements and recognized standards
• Verifying and assessing quality documents, records, and other evidence from medical device manufactures, to determine the state of their Quality Management System, in accordance with regulatory requirements and recognized standards
• Collaborating with internal stack holders to support the business growth of DQS US MED, by providing trainings, mentoring, and other activities
• Perform other duties as assigned.

EXPERIENCE/EDUCATION REQUIRED:

• Successful completion of a university degree in technical, medical or applied sciences studies or equivalent professional qualification in relevant courses, e.g., medicine, pharmacy, engineering or other relevant science; in individual cases: conclusion as instead. Certified technician with additional work experience
• Four years of professional experience in the field of medical device or related activities such as manufacturing, testing or research
• At minimum two years of demonstrated auditing experience in the field of medical device in accordance with regulatory requirements and recognized standards
• Adequate knowledge and experience in relevant harmonized standards, product designs, as well as risk management and the related standards and guidelines
• Adequate knowledge of quality management and related standards and guidelines
• Adequate knowledge and experience in the field of clinical evaluation

DQS Inc. is an Equal Opportunity Employer. Minorities/Women/Veterans/Disabled