Contract Opportunity - Medical Device Auditors

SGS

14h

About The Position

We are looking for Contract Medical Device Auditors with the following preferred experience:
Non-active cardiovascular, vascular, and neurovascular implants (2+ years)
Non-active, non-implantable ophthalmologic devices (2+ years)
Sterilization experts (EtO, Irradiation, Moist Heat)
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.

Requirements

• 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.
• 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
• Travels up to 80% of the time (automobile & airplane).
• Must be able to travel to both US and Canada
• Weekend travel may be necessary to meet scheduling requirements.

Nice To Haves

• 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
• Possesses Auditor Credentials for one or more of these standards: ISO 13485, MDSAP, MDD and MDR

Responsibilities

• 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

What This Job Offers

• Career Level: Mid Level