Contract Opportunity - Medical Device Auditors

This is a Contract role - must be authorized to travel to and provide auditing services in the United States, Canada and Mexico.

We are looking for Contract Medical Device Auditors with:

• 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

As a Contract Medical Device Auditor, you will perform third-party audits per SGS Certification procedures and the requirements for standards such as ISO 13485, MDSAP, MDD and MDR. You 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.  

• 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

Education and Experience

• Bachelor’s degree in a related discipline (i.e., Engineering, Bioscience, Biomedical, Science, etc.) AND
• Minimum 4 years of experience working with medical devices under ISO 13485, MDSAP, MDD and/or MDR compliant QMS.
• Preferred: Possesses Auditor Credentials for one or more of these standards:   ISO 13485, MDSAP, MDD and MDR
• Preferred: experience with ISO 14001, ISO 45001 and/or ISO 50001 based management systems
• Preferred: GMP (pharmaceutical, cosmetics, dietary supplements, etc.) quality / regulatory experience

Knowledge/ Skills/ Abilities

• 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
• Language Skills: Highest advanced level of English, additionally Spanish preferred
• 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
• Computer Skills
• MS Office Suite (Word, Excel, PowerPoint) – Intermediate user proficiency

Travel

• Travels up to 80% of the time (automobile & airplane).  
• Weekend travel may be necessary to meet scheduling requirements.