Certification Auditor, Senior (Medical Devices)

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 arm