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; supportsdispositions, defect coding, trending, and escalation to CAPA or SCAR, as appropriate.
- Owns manufacturing CAPAs as assigned, from initiation through closure, including rootcause investigation, action planning, implementation, and verification of effectiveness.
- Authors and revises manufacturing and supply chain SOPs and assists with updates to workand assembly instructions through the change order process.
- Generates, reviews, and uploads Device History Record (OHR) documentation for eachdevice built, in accordance with applicable procedures, ensuring complete traceability.
- Performs OHR reviews to verify that production documentation is complete, accurate, andappropriately executed prior to final release.
- Supports receiving inspection dispositions, supplier evaluations, SCAR issuance andtracking, 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 supplychain 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.