Medical Device Auditor

This is a fully remote position, open to applicants in United States.

📋 Description

• Conduct third-party audits in accordance with SGS Certification procedures and standards, including ISO 13485, MDSAP, MDD, and MDR.

• Make pertinent decisions related to the audit process and communicate with SGS to address issues outside the audit scope.

• Gather and evaluate sufficient information to provide certification recommendations.

• Execute audits of clients’ medical device quality systems and technical documentation against ISO 13485 and regulatory standards such as MDSAP, MDD, MDR, and EU regulations.

• Assess audit evidence to determine if registration should be recommended or permitted to continue.

• Engage in witness audits conducted by SGS or accreditation bodies.

• Maintain all audit credentials.

• Comply with internal standards, policies, and procedures.

• Travel up to 80% via automobile and airplane.

• Conduct audits in Canada and Mexico.

• Weekend travel may be required to fulfill scheduling obligations.

⛳️ Requirements

• Bachelor’s degree in a relevant field such as Engineering, Bioscience, Biomedical, or Science.

• A minimum of 4 years of experience working with medical devices in ISO 13485, MDSAP, MDD, and/or MDR-compliant quality management systems.

• At least 2 years of direct sterilization experience, primarily with EO and Gamma, is required.

• Preferred experience with cardiovascular soft tissue implants (MDN1101) and/or general non-active non-implantable healthcare devices (MDN1214).

• Preferred experience with management systems based on ISO 14001, ISO 45001, and/or ISO 50001.

• Auditor credentials for one or more of ISO 13485, MDSAP, MDD, and MDR are preferred.

• Preferred experience with non-active cardiovascular, vascular, and neurovascular implants.

• Preferred experience with non-active, non-implantable ophthalmologic devices.

• Preferred expertise in sterilization methods such as ETO, irradiation, and moist heat.

• ISO 9001 qualification is preferred.

• Strong background and comprehension of the technical applications of the standards.

• Proficient in English at an advanced level.

• Excellent communication, interpersonal, verbal, written, and presentation abilities.

• Proactive mindset and exceptional organizational skills.

• Capability to respond effectively in high-pressure situations and make clear, well-founded conformity decisions during audits.

• Ability to handle multiple tasks and manage several projects while delivering results punctually.

• Act with integrity, tact, and professionalism.

• Intermediate proficiency in MS Office Suite, including Word, Excel, and PowerPoint.

• Must be authorized to travel and provide auditing services in the United States, Canada, and Mexico.

• Willingness to travel up to 80% by automobile and airplane.

• Weekend travel may be necessary.

🏝️ Benefits

• Employees have the option to work remotely.

• This is a contract opportunity.

• Travel reimbursement or arrangements are not specifically stated.

• We are an Equal Opportunity Employer.

• Reasonable accommodations are available.