QA Specialist, Medical Devices — Product Ops & Compliance

Zywie, Inc.; Duluth (GA); On-site; USD 65,000 - 85,000; Full time

Job summary

Zywie, Inc. is seeking a Quality Assurance Specialist – Product Operations to ensure the quality and regulatory compliance of remote cardiac monitoring devices. This role sits at the intersection of quality systems and product operations within a distributed medical device company.

Responsibilities include conducting QC checks, maintaining CAPAs, supporting audits, and collaborating across R&D, Clinical, and Regulatory teams to drive quality improvements.

Qualifications

• Bachelor's degree in a relevant field or equivalent experience.
• 2–4+ years of QA experience in medical devices or regulated industry.
• Working knowledge of ISO 13485, 21 CFR Part 820, FDA QSR.

Responsibilities

• Execute quality control checks on workflows to ensure regulatory compliance.
• Review and maintain quality records (CAPAs, NCRs, deviations, complaints).
• Assist with internal and external audits/inspections (FDA, ISO).
• Monitor product performance and report quality risks.
• Maintain SOPs and version control with Product Operations.
• Support complaint handling and investigation processes.
• Contribute to root cause analysis and CAPA development.
• Maintain training records for quality system compliance.
• Collaborate with R&D, Clinical, Regulatory on quality initiatives.

Skills

Quality Systems

Regulatory Knowledge

CAPA

Documentation

Audit Support

Remote Collaboration

Education

Bachelor's degree in Quality/Engineering/Life Sciences or equivalent

Tools

Document Control

CAPA Software

Job description

Zywie, Inc. is seeking a Quality Assurance Specialist – Product Operations to ensure the quality and regulatory compliance of remote cardiac monitoring devices. This role sits at the intersection of quality systems and product operations within a distributed medical device company.

Responsibilities include conducting QC checks, maintaining CAPAs, supporting audits, and collaborating across R&D, Clinical, and Regulatory teams to drive quality improvements.