Certification Auditor Senior Medical Devices
Certification Auditor Senior Medical Devices
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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
- 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 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
- Bachelors 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 wellfounded 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 $90000$125000/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 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 :
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 :
Yes
Employment Type :
Fulltime
Employment Type
Remote
Company Industry
Key Skills
- Auditing
- Accounting Software
- Data Analytics
- GAAP
- Accounting
- Analysis Skills
- SOX
- Financial Analysis
- Financial Report Interpretation
- Internal Audits
- Mentoring
- GAAS
