Manufacturing Quality Specialist

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.