Med Device Quality & CAPA Specialist

CardioQuip, LLC; College Station (TX); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Health insurance

Retirement plan

Team culture

Paid time off

Job summary

CardioQuip, LLC is seeking a Manufacturing Quality Specialist to uphold product quality in a medical device environment. You will investigate nonconformances, participate in MRB decisions, and own CAPAs from initiation through verification, while ensuring complete Device History Records (OHR) and traceability across production.

The role collaborates with Production, Document Control, and Quality leadership to maintain FDA and ISO compliances and supports audits and inspections as needed.

Qualifications

• Must have 2 years manufacturing or quality experience; medical device experience preferred.
• Knowledge of ISO 13485:2016, 21 CFR 820 (QMS) preferred.
• ASQ CQA, CQE, or CQT certification preferred.

Responsibilities

• Originates and investigates manufacturing nonconformances per procedures; quarantines and controls nonconforming material.
• Represents Manufacturing on MRB and supports CAPA, SCAR, and escalation.
• Owns manufacturing CAPAs from initiation to closure with root cause analysis and verification.
• Authors and revises manufacturing/SOPs and updates work and assembly instructions via the change order process.
• Generates and verify Device History Records (OHR) for each device, ensuring traceability.

Skills

Technical drawings

Root cause analysis

MS Office

Attention to detail

Education

Associate or Bachelor’s degree

Tools

ERP

Electronic Document Control

Job description

CardioQuip, LLC is seeking a Manufacturing Quality Specialist to uphold product quality in a medical device environment. You will investigate nonconformances, participate in MRB decisions, and own CAPAs from initiation through verification, while ensuring complete Device History Records (OHR) and traceability across production.

The role collaborates with Production, Document Control, and Quality leadership to maintain FDA and ISO compliances and supports audits and inspections as needed.