Medical Device Auditor
SGS
contract
Posted on:
Location Type: Remote
Location: Canada
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About the role
- Perform third-party audits per SGS Certification procedures for ISO 13485, MDSAP, MDD and MDR
- Collect and analyze sufficient information to provide a recommendation for certification
- Decide upon evidence gained during audits whether or not registration should be recommended
- Participate actively in witness audits by SGS or accreditation bodies
- Maintain all audit credentials
- Adhere to internal standards, policies, and procedures
Requirements
- Bachelor’s degree in a related discipline (i.e., Engineering, Bioscience, Biomedical, Science, etc.)
- Minimum 4 years of experience working with medical devices under ISO 13485, MDSAP, MDD and/or MDR compliant QMS.
- Possesses Auditor Credentials for one or more of these standards: ISO 13485, MDSAP, MDD and MDR
- Knowledge of Non-active cardiovascular, vascular, and neurovascular implants
- Knowledge of Non-active, non-implantable ophthalmologic devices
- Knowledge of Sterilization experts (EtO, Irradiation, Moist Heat)
- Knowledge of ISO 9001 qualification
- Highest advanced level of English
- Excellent communication and interpersonal, verbal, written and presentation skills
- Proactive attitude and excellent organizational skills
- Ability to multitask and manage multiple projects while delivering results on time
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
ISO 13485MDSAPMDDMDRAuditor CredentialsSterilization (EtO, Irradiation, Moist Heat)ISO 9001Medical DevicesQuality Management System (QMS)Data Analysis
Soft Skills
CommunicationInterpersonal SkillsOrganizational SkillsProactive AttitudeMultitaskingProject ManagementVerbal SkillsWritten SkillsPresentation Skills