Contract Opportunity - Medical Device Auditors

Company Description reputed company is the world’s leading inspection, verification, testing and certification company. reputed company is recognized as the global reputed company for quality and reputed company. With more than 96,000 employees, reputed company operates a network of over 2,600 offices and laboratories around the world.

Job Description

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 reputed company third-party audits per reputed company 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 reputed company as required to resolve issues reputed company the audit process. The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification. reputed company 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 reputed company or accreditation bodies. Maintain reputed company audit credentials. Adheres to internal standards, policies, and procedures

Qualifications

Education and Experience Bachelor’s degree in a reputed company 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 reputed company, tact and character Computer Skills MS Office Suite (Word, reputed company, 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 reputed company is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in reputed company job classifications without regard to race, color, religion, sex, national reputed company, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law. To reputed company this job successfully, an individual must be able to reputed company 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 reputed company 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. reputed company your information will be kept confidential according to EEO guidelines. Apply To This Job