Auditor, Active Medical Devices (Remote) - 743999979875355-5844 - SGS North America Inc.
Lincolnshire, IL
About the Job
This job was posted by https://illinoisjoblink.illinois.gov : For more
information, please see:
https://illinoisjoblink.illinois.gov/jobs/12318709 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 Active 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 Active 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 Active Medical Device Auditor is
responsible to collect and analyze sufficient information to provide a
recommendation for certification. The Active 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
- 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 & 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
- 4+ years of experience related to information security or cyber
security
- 2+ years of experience related to AI systems
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
profi iency
TRAVEL
- Travels up to 80% of the time - automobile / airplane, some travel
might be international with flight time 8+ hours depending on the
destination. Weekend travel may be necessary to meet utilization
requirements.
Salary - $87,000 - $115,000/yr based on experience
Benefits - This position offers medical, dental, vision, 401K, time
off benefits
Additional Information
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. The requirements listed above are representative of the
knowledge, skills, and/or abilities required
information, please see:
https://illinoisjoblink.illinois.gov/jobs/12318709 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 Active 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 Active 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 Active Medical Device Auditor is
responsible to collect and analyze sufficient information to provide a
recommendation for certification. The Active 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
- 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 & 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
- 4+ years of experience related to information security or cyber
security
- 2+ years of experience related to AI systems
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
profi iency
TRAVEL
- Travels up to 80% of the time - automobile / airplane, some travel
might be international with flight time 8+ hours depending on the
destination. Weekend travel may be necessary to meet utilization
requirements.
Salary - $87,000 - $115,000/yr based on experience
Benefits - This position offers medical, dental, vision, 401K, time
off benefits
Additional Information
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. The requirements listed above are representative of the
knowledge, skills, and/or abilities required
Source : SGS North America Inc.
