Contract Opportunity Medical Device Auditors
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Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
We are looking for Contract Medical Device Auditors with the following preferred experience:
- Non-active cardiovascular vascular and neurovascular implants (2 years)
- Non-active non-implantable ophthalmologic devices (2 years)
- Sterilization experts (EtO Irradiation Moist Heat)
- ISO 9001 qualification
As a Contract Medical Device Auditor you will perform third-party audits per SGS Certification procedures and the requirements for standards such as ISO 13485 MDSAP MDD and MDR. You will be responsible for making relevant decisions concerning the audit process and to inform SGS as required to resolve issues outside the audit process. The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification.
- Perform audits for clients medical device quality systems and technical information to the requirements of ISO 13485 and other regulatory requirements such as MDSAP MDD MDR and EU.
- Decide upon evidence gained during audits whether or not registration should be recommended or allowed to continue.
- Participate actively in witness audits by SGS or accreditation bodies.
- Maintain all audit credentials.
- Adheres to internal standards policies and procedures
Qualifications :
Education and Experience
- Bachelors degree in a related discipline (i.e. Engineering Bioscience Biomedical Science etc.) AND
- Minimum 4 years of experience working with medical devices under ISO 13485 MDSAP MDD and/or MDR compliant QMS.
- Preferred: Possesses Auditor Credentials for one or more of these standards: ISO 13485 MDSAP MDD and MDR
Knowledge/ Skills/ Abilities
- Preferred Experience with:
- Non-active cardiovascular vascular and neurovascular implants
- Non-active non-implantable ophthalmologic devices
- Sterilization experts (EtO Irradiation Moist Heat)
- ISO 9001 qualification
- Strong background and knowledge of technical applications of the standards
- Language Skills: Highest advanced level of English
- Excellent communication and interpersonal verbal written and presentation skills
- Proactive attitude and excellent organizational skills
- Effectively reacts in stressful situations and makes 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).
- Must be able to travel to both US and Canada
- Weekend travel may be necessary to meet scheduling requirements.
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 on-line employment application because of a disability please call 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.
Remote Work :
Yes
Employment Type :
Contract
Key Skills
- IVR
- SOAP
- Avaya
- Solaris
- Cost Accounting Standards
- Database Design
- Hibernate
- ITIL
- Weblogic
- Express.js
- Contracts
- ASP
About Company
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 ... View more
