Contract Opportunity - Medical Device Auditors

SGS • Remote, REMOTE

127d • Remote

About The Position

SGS is seeking Contract Medical Device Auditors to perform third-party audits for clients' medical device quality systems and technical information. Auditors will assess compliance with standards such as ISO 13485, MDSAP, MDD, and MDR, making critical decisions regarding certification. The role involves collecting and analyzing audit evidence, participating in witness audits, and maintaining audit credentials. Auditors must adhere to SGS procedures and internal standards.

Requirements

• Bachelor’s degree in a related discipline (i.e., Engineering, Bioscience, Biomedical, Science, etc.)
• Minimum 4 years of experience working with medical devices under ISO 13485, MDSAP, MDD and/or MDR compliant QMS.
• Strong background and knowledge of technical applications of the standards
• Highest advanced level of English
• Excellent communication and interpersonal, verbal, written and presentation skills
• Proactive attitude and excellent organizational skills
• Effectively reacts in stressful situations and makes clear, well-founded decisions regarding conformity during the audit
• Ability to multitask and manage multiple projects while delivering results on time
• Act with integrity, tact and character
• MS Office Suite (Word, Excel, PowerPoint) – Intermediate user proficiency

Nice To Haves

• Non-active cardiovascular, vascular, and neurovascular implants (2+ years)
• Non-active, non-implantable ophthalmologic devices (2+ years)
• Sterilization experts (EtO, Irradiation, Moist Heat)
• ISO 9001 qualification
• Possesses Auditor Credentials for one or more of these standards: ISO 13485, MDSAP, MDD and MDR

Responsibilities

• Perform third-party audits per SGS Certification procedures and the requirements for standards such as ISO 13485, MDSAP, MDD and MDR.
• Make relevant decisions concerning the audit process and inform SGS as required to resolve issues outside the audit process.
• Collect and analyze sufficient information to provide a recommendation for certification.
• Perform audits for clients’ medical device quality systems and technical information to the requirements of ISO 13485 and other regulatory requirements such as MDSAP, MDD, MDR and EU.
• Decide upon evidence gained during audits whether or not registration should be recommended or allowed to continue.
• Participate actively in witness audits by SGS or accreditation bodies.
• Maintain all audit credentials.
• Adheres to internal standards, policies, and procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior