Auditor, Active Medical Devices (Remote) - 743999979875355-5844

SGS • Lincolnshire, IL

399d • $87,000 - $115,000 • Remote

About The Position

The Active Medical Device Auditor at SGS North America Inc. is responsible for conducting third-party audits in accordance with ISO 13485, MDSAP, MDD, and MDR standards. This remote position requires the auditor to make critical decisions regarding the audit process, collect and analyze information for certification recommendations, and manage audit teams effectively. The role emphasizes maintaining audit credentials and adhering to internal standards while ensuring efficient and commercially expedient audit practices.

Requirements

• Bachelor's degree in a related discipline (i.e., Engineering, Bioscience, Biomedical, Science, etc.)
• Minimum 5 years of experience auditing for ISO 13485, MDSAP, MDD and MDR standards.
• Possesses Auditor Credentials for ISO 13485, MDSAP, MDD and MDR standards.
• 4+ years of experience related to information security or cyber security.
• 2+ years of experience related to AI systems.
• Strong background and knowledge of technical applications of the standards.
• Excellent communication and interpersonal skills.

Nice To Haves

• Proactive attitude and excellent organizational skills.
• Ability to multitask and manage multiple projects while delivering results on time.
• Leadership abilities to lead a team to achieve set goals.

Responsibilities

• Perform audits for clients' medical devices quality systems and technical information to the requirements of ISO 13485 and other regulatory requirements such as MDSAP, MDD, MDR and EU.
• Control teams of auditors during audit activities.
• Decide upon evidence gained during audits whether or not registration should be recommended or allowed to continue.
• Acquire sufficient audit experience to cover SGS's Certification's accredited activities.
• Assist in the training of other auditors and lead auditors during planned audits or training functions.
• Participate actively in witness audits by SGS or accreditation bodies.
• Maintain all audit credentials.
• Undertake any other activities as directed by the Operations and/or Accreditation Manager.
• Lead the audit team, which can range from one to fifteen members, depending on the assignment.
• Adhere to internal standards, policies, and procedures.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401K
• Time off benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees