Contract Opportunity - Medical Device Auditors

SGS•Remote, REMOTE

3h•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 recommendations. The role involves collecting and analyzing audit evidence, participating in witness audits, and maintaining audit credentials. Auditors must adhere to SGS's procedures and internal standards.

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
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

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
Strong background and knowledge of technical applications of the standards

Responsibilities

Perform third-party audits per SGS Certification procedures and the requirements for standards such as ISO 13485, MDSAP, MDD and MDR.
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.
Make relevant decisions concerning the audit process and to inform SGS as required to resolve issues outside the audit process.
Collect and analyze sufficient information to provide a recommendation for certification.
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