Manufacturing Quality Specialist

CardioQuip • College Station, TX

2d

About The Position

CardioQuip is seeking a Manufacturing Quality Specialist to help ensure the functionality and reliability of products manufactured for medical applications. The role works regularly with Production, Document Control, and the Director of Quality and Regulatory, and reports directly to the Director of Manufacturing. It supports manufacturing and supply-chain quality processes, product documentation, inspections, audits, and quality metrics.

Requirements

• At least two years of manufacturing or quality experience.
• Ability to read and interpret technical drawings, bills of material, and assembly instructions.
• Ability to apply good documentation practices (GDP) and structured root-cause analysis methods.
• Proficiency with Microsoft Office Suite.
• Strong attention to detail, sound judgment, and clear communication with production teams.

Nice To Haves

• Medical device experience.
• Associate or bachelor's degree in a technical or quality discipline.
• Knowledge of ISO 13485:2016, 21 CFR 820 (QMSR), and EU MDR 2017/745.
• Hands-on experience with nonconformance, CAPA, and OHR processes.
• Experience with ERP and electronic document-control systems.
• ASQ CQA, CQE, or CQT certification.

Responsibilities

• Originate and investigate manufacturing nonconformances; ensure nonconforming material is identified, quarantined, and controlled.
• Represent Manufacturing on the Material Review Board (MRB), as appointed, and support dispositions, defect coding, trending, and escalation to CAPA or SCAR as appropriate.
• Own assigned manufacturing CAPAs from initiation through closure, including root-cause investigation, action planning, implementation, and effectiveness verification.
• Author and revise manufacturing and supply-chain SOPs, and assist with updates to work and assembly instructions through the change-order process.
• Generate, review, and upload Device History Record (OHR) documentation for each device built, ensuring complete traceability in accordance with applicable procedures.
• Review OHRs to verify production documentation is complete, accurate, and appropriately executed before final release.
• Support receiving-inspection dispositions, supplier evaluations, SCAR issuance and tracking, and CAPA-related communication with suppliers and contract manufacturers.
• Assist the Quality Inspector with manufacturing-floor inspections as needed.
• Support internal audits and FDA/notified body inspections of manufacturing and supply-chain areas.
• Prepare production quality metrics for management review.
• Perform other duties as assigned.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• Retirement savings plan with company contribution
• Paid time off, including vacation days and holidays
• Supportive team culture that values innovation, improvement, and empowerment

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed