Medical Device Auditor
SGS North America Inc.

Job Info

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Company Description

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 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Job Description

As the 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 Medical Device Auditor is responsible to collect and analyze sufficient information to provide a recommendation for certification. The 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 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

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.

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 Constantly
Taste/Smell Occasionally
Lift/carry/push or pull Frequently 30 Lbs

Work Schedule

• Business hours are Monday through Friday, 8:00 a.m. to 5:00 p.m.
• Work requires willingness to work a flexible schedule.
• Travel time may be 8+ hours in a day.
• Longer hours, evenings and/or weekend work will be necessary frequently as job duties demand
  

Additional Information

In the course of employment, you will be required to travel to and/or work at a client site. The company requires employees to be vaccinated against COVID-19 in order to travel commercially and many clients require visitors performing work at their locations to be vaccinated. Therefore, this role requires a candidate who is fully vaccinated or will be prior to an anticipated start date. The successful candidate will be required to provide proof of having received a COVID-19 vaccination.

The company will provide a reasonable accommodation upon request after an offer is extended.

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.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability

All your information will be kept confidential according to EEO guidelines.

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