CorDx · 15 hours ago
Quality Assurance Specialist
Alpharetta, GA
Full-time
Onsite
Entry Level
1+ years expCorDx is a multi-national biotech organization focused on innovation in global health. They are seeking a Quality Assurance Specialist to support the Quality Management System in accordance with ISO 13485 and assist with various quality assurance tasks.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Support the Quality Management System (QMS) in accordance with ISO 13485 and applicable regulatory requirements
Report to the Quality Manager/Supervisor, provide timely status updates, and complete assigned tasks on schedule
Review and maintain QC and quality records, including inspection records and batch documentation
Assist in identifying nonconformities and support investigation and corrective action activities under supervision
Support equipment qualification and validation documentation activities
Assist with drafting and updating SOPs and quality record forms as needed
Use the company’s eQMS for document control, training records, and CAPA/change management support
Support internal and external audits and related follow-up activities
Collaborate with QC, production, and other departments to support quality compliance and daily operations
Qualification
Required
1–3 years of experience in Quality Assurance and/or Quality Control, preferably in IVD or medical device manufacturing
Basic working knowledge of ISO 13485 and quality system requirements
Experience reviewing quality records and maintaining documentation
Good written and verbal communication skills, with the ability to follow instructions and report progress clearly
Strong sense of responsibility, timely task execution, and a positive work attitude
Preferred
Familiarity with eQMS systems preferred
Exposure to equipment validation activities is a plus
Benefits
Competitive compensation package.
Comprehensive medical Insurance.
401(k) plan with company contributions.
Flexible paid time off (PTO) policy.
Company
CorDx
CorDx provides medical device solutions to the healthcare industry.
1001-5000 employees
H1B Sponsorship
CorDx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2023 (2)
Funding
Current Stage
Late StageRecent News
2025-03-26
Company data provided by crunchbase