Senior Quality Control Leader, Medical Devices

ROMTech; Brookfield (CT); Hybrid; USD 120,000 - 125,000; Full time

Job summary

ROMTech in Brookfield, CT is seeking a Quality Control Manager to lead the inspection teams across incoming, in-process, repair/upgrade, and final release. You will ensure compliance with FDA QSR (21 CFR 820), ISO 13485, and internal QMS while driving continuous improvement and robust data-driven decisions.

You will build staffing plans, oversee audits, CAPA programs, and collaborate with Production, Engineering, and Supply Chain to reduce defects and escapes, delivering patient-ready

Qualifications

• 7+ years of technical experience in quality, manufacturing, medical device, or regulated production environments.
• 3+ years of experience as a Quality Inspector Lead, Supervisor, or equivalent people-lead role.
• Proven experience overseeing incoming, in-process, repair, and final inspection programs.
• Experience working within an FDA-regulated environment (21 CFR 820 / QMS).
• Demonstrated experience managing nonconformances, investigations, and CAPA.
• Experience supporting internal and external audits.

Responsibilities

• Lead, coach, and develop the Quality Inspector team.
• Oversee incoming, in process, repair/upgrade, and final inspection operations.
• Ensure inspection standards, sampling plans, and risk based approaches.
• Serve as approver for device release when required.
• Address daily line support issues and drive resolution.
• Maintain inspection procedures, work instructions, and documentation.
• Provide dashboards and reporting on key quality indicators.

Skills

Quality leadership

CAPA

FDA QMS

Cross-functional

Data-driven

Audits

Job description

ROMTech in Brookfield, CT is seeking a Quality Control Manager to lead the inspection teams across incoming, in-process, repair/upgrade, and final release. You will ensure compliance with FDA QSR (21 CFR 820), ISO 13485, and internal QMS while driving continuous improvement and robust data-driven decisions.

You will build staffing plans, oversee audits, CAPA programs, and collaborate with Production, Engineering, and Supply Chain to reduce defects and escapes, delivering patient-ready