Certification Auditor, Senior (Medical Devices) - 744000049835497-5844

SGS North America Inc. • Lincolnshire, IL • 4w ago

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/12626431 Company Description

We are SGS - the world\'s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

As the Senior Medical Device Auditor, you will perform third-party audits per SGS Certification procedures and the requirements for ISO 13485, MDSAP, MDD and MDR standards. The Sr. Medical Device Auditor is responsible to make relevant decisions concerning the audit process and to inform SGS SSC as required to resolve issues outside the audit process. The Sr. Medical Device Auditor is responsible to collect and analyze sufficient information to provide a recommendation for certification. The Sr. Medical Device Auditor has the authority for the control and performance of auditing activities including planning and the control of other members of audit teams.

Remote position can be located anywhere in the United States

Must have experience with ophthalmology medical devices

Perform audits for clients\' medical devices quality systems and

technical information to the requirements of ISO 13485 and other regulatory requirements such as MDSAP, MDD, MDR and EU.

In performing the duties described above, to ensure that such duties

are performed in an efficient and commercially expedient way.

To control as necessary, teams of auditors during the activities

covered by items above.

Decide upon evidence gained during audits whether or not

registration should be recommended or allowed to continue.

Strive to acquire sufficient audit experience to cover the whole of

SGS\'s Certification\'s accredited activities.

Assist in the training of other auditors and lead auditors during

planned audits or during other training functions.

Participate actively in witness audits by SGS or accreditation

bodies.

Maintain all audit credentials.

Undertake any other activities as directed by the Operations and/or

Accreditation Manager.

As a Lead assessor you are responsible for the overall audit team.

The team could be one person or 15 people depending on the assignment.

Adheres to internal standards, policies, and procedures.

Performs other duties as assigned.

Qualifications

Education and Experience

Bachelor\'s degree in a related discipline (i.e., Engineering,

Bioscience, Biomedical, Science, etc.) AND

Minimum 5 years of experience auditing for ISO 13485, MDSAP, MDD and

MDR standards.

Possesses Auditor Credentials for either of these standards: ISO

13485, MDSAP, MDD and MDR

Must have experience with ophthalmology medical devices

Knowledge/ Skills/ Abilities

Strong background and knowledge of technical applications of the

standards

Language Skills: Highest advanced level of English

Mathematical Skills: Basic level

Reasoning Skills/Abilities: Basic level

Excellent communication and interpersonal, verbal, written and

presentation skills

Leadership abilities - ability to Lead a team to achieve a set up

goal or complete an audit on time and according to standards

Proactive attitude and excellent organizational skills

Effectively reacts in stressful situations and make 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).

**Some travel may be international with flights of 8+ hours

depending on the destination.**

**Weekend travel may be necessary to meet utilization

requirements.

Salary**

Salary - \$90,000-\$125,000/year (based on experience)

Physical/Sensory Demands Frequency Requirements:

Frequency Weight lbs/kg

Stand Frequently

Move or traverse Constantly

Sit Frequently

Use hands Constantly

Reach with hands and arms Occasionally

Climb or balance Occasionally

Stoop, kneel, crouch or crawl Occasionally

Talk/hear

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