GMED · 1 day ago
Lead Auditor
United States
Contract
Remote
Mid, Senior Level
4+ years expGMED North America is a leading Certification Organization focused on providing quality management services for medical device manufacturers. They are seeking a Medical Device QA Auditor to conduct ISO audits and ensure compliance with international standards while managing client portfolios and delivering audit services.
Health CareHealth DiagnosticsMedicalMedical Device
Hiring Manager
Ehab A.
Responsibilities
Deliver GMED NA’s third-party audit services to assigned clients in accordance with all GMED, scheme and regulatory requirements to assure timely, cost effective service delivery that assures satisfaction of our customer needs
Analyze quality systems and assess:
Quality Management Systems according to ISO Standards ISO 9001:2015 and ISO13485:2016
CE Marking certification under the applicable European Directives & Regulations:
Medical Devices 93/42/EEC (MDD)
Active Medical Device Implantable 90/385/EEC (AIMD)
In Vitro Diagnostics devices 98/79/EC (IVDD)
EU MDR 2017/745
EU IVDR 2017/746
Quality Management Systems under the requirements of the Medical Device Single Audit Program MDSAP
Manage a portfolio of assigned clients based on geographic location and a match of qualifications and client contract requirements
Client management includes contacting them to schedule the visit, planning the assessment, making appropriate travel plans, conducting assessments, completing reports, and managing results
Participate in professional development and training opportunities to achieve necessary certifications and statuses
Qualification
Required
Bachelor's degrees in computer and software technology, biology, chemistry, biochemistry, electrical/electronic/mechanical or bioengineering, human physiology, medicine, physics, or biophysics
A minimum of four years of full-time hands-on (R&D, manufacturing, testing and/or auditing) work experience in the field of medical devices or related sectors
At least two years in the area of quality management (experience working in an organization governed by regulations and standards)
Impartiality
Confidentiality
Ability to function independently and in a team environment
Organizational skills & time management
Attention to details
Strong oral and written communication skills
Critical reasoning
Decision making
English language skills
Leadership skills
Ability to draw up demonstrative records and reports
Reliability and accountability
Benefits
Group-sponsored health, dental, and vision coverage
Flexible spending accounts
Short-term and long-term disability
Company-paid life insurance
Competitive base salary
Annual bonus based on company performance
401K retirement program
Option to telework
Flexible working arrangements
Generous time off program
Paid holidays
Paid bereavement leave
Paid parental leave
Commuter benefits program for public transportation
Internet stipend
Company
GMED
With GMED and its subsidiaries, GMED North America and GMED Asia, access all your target markets whether your MDs and IVDs are high risk or use innovative technologies.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase