Contract Opportunity - Medical Device Auditors

SGS • Remote, REMOTE

3h • Remote

About The Position

This is a Contract role where the individual will provide auditing services in the United States, Canada, and Mexico. The Medical Device Auditor will perform third-party audits per SGS Certification procedures and the requirements for standards such as ISO 13485, MDSAP, MDD, and MDR. Responsibilities include making relevant decisions concerning the audit process, informing SGS to resolve issues, and collecting and analyzing sufficient information to provide a recommendation for certification. The role involves performing audits for clients’ medical device quality systems and technical information, deciding on evidence for registration recommendations, and participating in witness audits. The auditor must also maintain all audit credentials and adhere to internal standards, policies, and procedures.

Requirements

• 2+ years of direct Sterilization (primarily EO and Gamma) experience
• 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.
• Highest advanced level of English
• Strong background and knowledge of technical applications of the standards
• 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
• Must be authorized to travel to and provide auditing services in the United States, Canada and Mexico.

Nice To Haves

• Experience with cardiovascular soft tissue implants (MDN1101) and/or general non-active non-implantable devices used in healthcare and others non-actives non-implantable devices (MDN1214)
• Experience with ISO 14001, ISO 45001 and/or ISO 50001 based management systems
• Possesses Auditor Credentials for one or more of these standards: ISO 13485, MDSAP, MDD and MDR
• Non-active cardiovascular, vascular, and neurovascular implants
• Non-active, non-implantable ophthalmologic devices
• Sterilization experts (ETO, Irradiation, Moist Heat)
• ISO 9001 qualification

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

• Career Level: Senior