[Hiring] Contract Opportunity - Medical Device Auditors @SGS

Role Description

We are looking for Contract Medical Device Auditors with:

• 2+ years of direct Sterilization (primarily EO and Gamma) experience (required)
• Experience with cardiovascular soft tissue implants (MDN1101) and/or general non-active non-implantable devices used in healthcare and others non-active non-implantable devices (MDN1214) (preferred)
• Experience with ISO 14001, ISO 45001 and/or ISO 50001 based management systems (preferred)

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 informing SGS as required to resolve issues outside the audit process.
• Collecting and analyzing sufficient information to provide a recommendation for certification.
• 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.
• Deciding upon evidence gained during audits whether or not registration should be recommended or allowed to continue.
• Participating actively in witness audits by SGS or accreditation bodies.
• Maintaining all audit credentials.
• Adhering to internal standards, policies, and procedures.

Qualifications

• 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:
  • 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.
• Language Skills: 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.

Requirements

• MS Office Suite (Word, Excel, PowerPoint) – Intermediate user proficiency.
• Travels up to 80% of the time (automobile & airplane).
• Must be able to travel to Canada and Mexico to perform audits.
• Weekend travel may be necessary to meet scheduling requirements.

Benefits

• 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.
• 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 on-line 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.