Manufacturing Quality Specialist

CardioQuip, LLC; College Station (TX); Presencial; USD 65.000 - 90.000; Tempo integral

Benefícios oferecidos por esta vaga

Competitive compensation

Health insurance

Retirement plan

Team culture

Paid time off

Resumo da vaga

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Technical drawings

Root cause analysis

MS Office

Attention to detail

Formação

Associate or Bachelor’s degree

Ferramentas

ERP

Electronic Document Control

Descrição da vaga

CardioQuip is a dynamic and innovative company specializing in the manufacturing, maintenance, and design of Cardiovascular Operating room technology. We are seeking a motivated Manufacturing Quality Specialist to join our team. This position plays a crucial role in ensuring the functionality and reliability of our products, which are vital for medical applications.

Direct Report: Director of Manufacturing

Works regularly with Production, Document Control, and the Director of Quality and Regulatory.

Responsibilities

• Originates and investigates manufacturing nonconformances per applicable procedures;
  ensures nonconforming material is properly identified, quarantined, and controlled.
• Represents Manufacturing on the Material Review Board (MRB), as appointed; supports
  dispositions, defect coding, trending, and escalation to CAPA or SCAR, as appropriate.
• Owns manufacturing CAPAs as assigned, from initiation through closure, including root
  cause investigation, action planning, implementation, and verification of effectiveness.
• Authors and revises manufacturing and supply chain SOPs and assists with updates to work
  and assembly instructions through the change order process.
• Generates, reviews, and uploads Device History Record (OHR) documentation for each
  device built, in accordance with applicable procedures, ensuring complete traceability.
• Performs OHR reviews to verify that production documentation is complete, accurate, and
  appropriately executed prior to final release.
• Supports receiving inspection dispositions, supplier evaluations, SCAR issuance and
  tracking, and CAPA-related communication with suppliers and contract manufacturers.
• Assists the Quality Inspector with inspections on the manufacturing floor, as needed.
• Supports internal audits and FDA/notified body inspections of manufacturing and supply
  chain areas and prepares production quality metrics for management review.
• Performs other duties as assigned.

Required Skills/Abilities

• Reads and interprets technical drawings, bills of material, and assembly instructions.
• Applies good documentation practices (GDP) and structured root cause analysis methods.
• Proficient with Microsoft Office Suite.
• Strong attention to detail, sound judgment, and clear communication with production teams.

Education and Experience

• Two years of manufacturing or quality experience required; medical device experience preferred.
• Associate or Bachelor's degree in a technical or quality discipline preferred.
• Knowledge of ISO 13485:2016, 21 CFR 820 (QMSR), and EU MOR 2017/745 preferred.
• Hands-on experience with nonconformance, CAPA, and OHR processes strongly preferred.
• Experience with ERP and electronic document control systems preferred.
• ASQ CQA, CQE, or CQT certification preferred.

Physical Requirements

• Must be able to traverse the distribution warehouse and access a variety of storage spaces and shelving units by stretching, squatting, and reaching.
• Must be able to lift up to 50 pounds at a time.

What We Offer

• Competitive Compensation
  • A fair salary commensurate with experience and qualifications.
• Comprehensive Benefits
  • Health, dental, and vision insurance.
  • Retirement savings plan with company contribution.
• Dynamic Work Environment
  • A supportive team culture that values innovation, improvement, and empowerment.
• Work-Life Balance
  • Paid time off, including vacation days and holidays.
• Fun and Engaging Culture
  • We believe in working hard and celebrating our successes together, fostering a sense of camaraderie and enjoyment in our work.

Why Join?

At CardioQuip, we are dedicated to empowering people towards better healthcare. As a leading company in the medical device industry, we design and manufacture advanced cardiovascular devices that make a real difference in patients' lives. Our humble beginnings started with just two founders in a small office, and we've grown into a dynamic team that values every member's contribution. We believe in fostering an environment where our team is empowered, customer-focused, and continually striving for improvement—all while having fun along the way.