Contract Opportunity - Medical Device Auditors

SGS is the world’s leading inspection, verification, testing and certification company, recognized as the global benchmark for quality and integrity. With more than 96,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

About the role

This is a contract role requiring authorization to travel to and provide auditing services in the United States, Canada, and Mexico. We are seeking Contract Medical Device Auditors with expertise in the following areas:

• 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 other non-active non-implantable devices (2+ years)
• Sterilization experts (primarily EtO, Irradiation, and Moist Heat, as well as other sterilization technologies)
• ISO 9001 qualification

Responsibilities

• Perform third-party audits per SGS Certification procedures and 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 regulations.
• Decide, based on evidence gained during audits, whether registration should be recommended or allowed to continue.
• Participate actively in witness audits by SGS or accreditation bodies.
• Maintain all audit credentials.
• Adhere to internal standards, policies, and procedures.

Requirements

• Bachelor’s degree in a related discipline (e.g., Engineering, Bioscience, Biomedical, Science).
• Minimum 4 years of experience working with medical devices under ISO 13485, MDSAP, MDD, and/or MDR compliant QMS.

Qualifications

• Preferred: 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.

Skills

• Expertise in non-active cardiovascular, vascular, and neurovascular implants (MDN1101).
• Expertise in non-active, non-implantable ophthalmologic devices (MDN1206).
• Expertise in general non-active non-implantable devices used in healthcare and other non-active non-implantable devices (MDN1214).
• Expertise in sterilization technologies (primarily EtO, Irradiation, and Moist Heat; other technologies also considered).
• ISO 9001 qualification.
• Strong background and knowledge of technical applications of the standards.
• Highest advanced level of English; Spanish preferred.
• Excellent communication and interpersonal, verbal, written, and presentation skills.
• Proactive attitude and excellent organizational skills.
• Ability to effectively react in stressful situations and make 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.
• Intermediate proficiency in MS Office Suite (Word, Excel, PowerPoint).

Schedule

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