Quality Assurance Specialist - Operations

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

Job Description

Job Description

Job Title: Quality Assurance Specialist – Product Operations

Reports To: Director/Manager, Product Operations (dotted line to Quality/Regulatory as applicable)

Location: Georgia On-site

FLSA Status: Exempt

Position Summary

Zywie, Inc. is seeking a QA Specialist to support Product Operations by ensuring the quality, compliance, and reliability of our remote cardiac monitoring devices and related workflows. This role sits at the intersection of quality systems and day-to-day product operations — verifying that processes, documentation, and outputs meet regulatory requirements (FDA, ISO 13485, 21 CFR Part 820) while supporting the operational cadence of a distributed medical device company.

Key Responsibilities

• Execute quality control checks on device-related workflows, documentation, and product operations processes to ensure compliance with applicable medical device regulations
• Review and maintain quality records (CAPAs, NCRs, deviations, complaint files) in coordination with Product Operations and Quality teams
• Support internal audits and prepare documentation for external audits/inspections (e.g., FDA, notified body, ISO surveillance)
• Monitor product performance and operational metrics, flagging trends that may indicate quality risks
• Partner with Product Operations to ensure standard operating procedures (SOPs) are followed, current, and properly version-controlled
• Assist with complaint handling and investigation processes, ensuring timely and compliant closure
• Support supplier/vendor quality reviews as they relate to product components or services
• Contribute to root cause analysis and corrective/preventive action development
• Maintain training records and documentation to support quality system compliance
• Collaborate cross-functionally with R&D, Clinical, and Regulatory teams on quality-related initiatives

Qualifications

• Bachelor's degree in a relevant field (Quality, Engineering, Life Sciences) or equivalent experience
• 2–4+ years of QA experience in medical device, healthcare technology, or a regulated industry
• Working knowledge of ISO 13485, 21 CFR Part 820, and FDA QSR requirements
• Experience with CAPA, complaint handling, and document control systems
• Strong attention to detail and process discipline
• Ability to work independently in a remote, distributed team environment
• Excellent written communication skills for audit-ready documentation

Preferred

• ASQ certification (CQA, CQE) a plus
• Experience in cardiac monitoring, remote patient monitoring, or connected medical devices