Contract Opportunity - Medical Device Auditors

SGS • Remote, REMOTE

22h • Remote

About The Position

This is a Contract role where 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. The auditor will be responsible for making relevant decisions concerning the audit process and to inform SGS as required to resolve issues outside the audit process. The Contract Medical Device Auditor is responsible for 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 to the requirements of ISO 13485 and other regulatory requirements such as MDSAP, MDD, MDR and EU. The auditor will decide upon evidence gained during audits whether or not registration should be recommended or allowed to continue. The role also includes participating actively in witness audits by SGS or accreditation bodies and maintaining all audit credentials.

Requirements

• Non-active cardiovascular, vascular, and neurovascular implants (2+ years)
• Non-active, non-implantable ophthalmologic devices (2+ years)
• General non-active non-implantable devices used in healthcare and others non-actives non-implantable devices (2+ years)
• Sterilization experts (primarily EtO, Irradiation and Moist Heat, as well as other sterilization technologies)
• ISO 9001 qualification
• 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.
• Non-active cardiovascular, vascular, and neurovascular implants (MDN1101)
• Non-active, non-implantable ophthalmologic devices (MDN1206)
• General non-active non-implantable devices used in healthcare and others non-actives non-implantable devices (MDN1214)
• Sterilization technologies (primarily EtO, Irradiation and Moist Heat, other technologies are also considered)
• ISO 9001 qualification
• 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

• Possesses Auditor Credentials for one or more of these standards: ISO 13485, MDSAP, MDD and MDR
• experience with ISO 14001, ISO 45001 and/or ISO 50001 based management systems
• GMP (pharmaceutical, cosmetics, dietary supplements, etc.) quality / regulatory experience
• Spanish preferred

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