Contract Opportunity - Medical Device Auditors

About the Position

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, SGS operates a network of over 2,600 offices and laboratories around the world with more than 96,000 employees.

We are seeking Contract Medical Device Auditors authorized to travel and provide auditing services in the United States, Canada, and Mexico.

Responsibilities

As a Contract Medical Device Auditor, you will:

• Perform third-party audits per SGS Certification procedures and the requirements of standards such as ISO 13485, MDSAP, MDD, and MDR.
• 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.
• Adhere to internal standards, policies, and procedures.

Requirements

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

• 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 other non-active 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 is 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.

We Offer

• Competitive contract role.
• Opportunity to work with a leading global inspection, verification, testing, and certification company.
• Professional development and growth opportunities.

About the Company

SGS is an Equal Opportunity Employer, and as such, we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities, or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the online employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

All your information will be kept confidential according to EEO guidelines.