SGS

Contract Opportunity - Medical Device Auditors

Work from home

Remote role where the employee must remain based in a particular country.

United States only

From the employer's advert: This is a Contract role - must be authorized to travel to and provide auditing services in the United States, Canada and Mexico.

Employer listed it 3 months ago · Added 2 weeks ago

Been open since 3 months ago. Long-running listings are sometimes left up after the role is filled.

Salary

Not stated

Location

United States only

Timezone

US East

Contract

Experience

Mid

What the advert says

Quoted word for word from the employer's advert. Where it says nothing, we say so.

Working hours: Not mentioned in the advert
Where you can work from: Location eligibility not confirmed
Contract: This is a Contract role - must be authorized to travel to and provide auditing services in the United States, Canada and Mexico.
Experience asked for: Minimum 4 years of experience working with medical devices under ISO 13485, MDSAP, MDD and/or MDR compliant QMS.
Pay: Not mentioned in the advert

Remote flexibility

Work from home

This is a remote role, but the employee must be based in United States. It is work from home rather than work from anywhere.

What the employer says

Source listing states candidate location: "Remote, REMOTE, United States, Remote, us"
Job description states: "United States, Canada and Mexico"

What Nomaders makes of it

Payroll and tax are likely handled in that country only

The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.

Before you apply

Experience: employer states

Written as a nice-to-have

“Preferred: experience with ISO 14001, ISO 45001 and/or ISO 50001 based management systems”
“Preferred: GMP (pharmaceutical, cosmetics, dietary supplements, etc.) quality / regulatory experience”

Questions worth asking: Nomaders interpretation

The advert does not say where you can be based. Ask which countries they can legally employ or contract you from.
No pay is stated. Ask for the salary range before investing time in interviews.

Produced automatically from this advert's text; not reviewed by a person. The employer's own page is the final word.

About the role

SGS is the world’s leading inspection, verification, testing and certification company. SGS is 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.

This is a Contract role - must be authorized to travel to and provide auditing services in the United States, Canada and Mexico.

We are looking for Contract Medical Device Auditors with:

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 others non-actives non-implantable devices (2+ years)

Sterilization experts (primarily EtO, Irradiation and Moist Heat, as well as other sterilization technologies)

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.  

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

Education and Experience

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 ISO 14001, ISO 45001 and/or ISO 50001 based management systems

Preferred: GMP (pharmaceutical, cosmetics, dietary supplements, etc.) quality / regulatory experience

Knowledge/ Skills/ Abilities

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 others non-actives non-implantable devices (MDN1214)

Requirements

·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

Benefits

No benefits package published with this listing. Ask about it at first interview.

How to apply

1Check the flexibility label above, work from home, matches where you plan to live and work.
2Tailor your CV to the role at SGS, mentioning your remote working experience and working hours (US East).
3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.

Found 17d ago. Last checked today. Always confirm the details on the original posting, salary and location can change after publication.

Listing sourced from Company boards.