What are the responsibilities and job description for the Certification Auditor Senior Medical Devices position at SGS?
As the Senior Medical Device Auditor you will perform thirdparty 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
- 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 SGSs Certifications 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
Knowledge / Skills / Abilities
Computer Skills
Travel
Salary
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
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.
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 companys 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 online employment application because of a disability please callfor 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.
Remote Work : Employment Type :
Fulltime
Salary : $90,000 - $125,000
