Quality Assurance / Quality Control Specialist

Omega Medical Imaging LLC•Sanford, FL

5d•Onsite

About The Position

Omega Medical Imaging is seeking a hands-on Quality Assurance / Quality Control Specialist to support day-to-day quality activities within our medical device manufacturing operations. This is a highly visible, hands-on Quality role that will spend significant time on the manufacturing floor supporting incoming inspection, nonconforming material, final inspection, calibration activities, and quality records. The ideal candidate enjoys working directly with products and people, has exceptional attention to detail, and is equally comfortable using calipers to inspect a component, reviewing an NCR for completeness, and helping ensure Quality processes are consistently followed. We're looking for someone with enough Quality experience to contribute quickly while still being eager to learn, collaborate, and grow within Omega's Quality organization.

Requirements

3+ years of hands-on Quality Assurance / Quality Control experience in an FDA and/or ISO-regulated manufacturing environment; medical device experience strongly preferred.
Working knowledge of regulated Quality systems, including experience with nonconforming material/NCRs and hands-on experience in areas such as incoming inspection, final inspection, calibration, and electronic Quality Management Systems.
Exceptional attention to detail, organization, and follow-through, with the ability to recognize inconsistencies, identify missing information, and manage multiple open items through completion.
Strong verbal and written communication skills, with the ability to clearly communicate Quality requirements, ask effective questions, document issues accurately, and work collaboratively with employees across different functions and experience levels.
Sound judgment and confidence to consistently apply Quality requirements, raise concerns appropriately, and recognize when additional information, discussion, or escalation is needed.
A seek-to-understand mindset; willing to learn existing processes and understand the rationale and requirements before drawing conclusions or recommending changes.
Adaptable and comfortable shifting between routine responsibilities, changing priorities, and unexpected Quality needs.
Comfortable working in an active manufacturing and machine-shop environment that includes CNC machining, welding, painting, electrical work, mechanical assembly, and related manufacturing operations.
Proficiency with Microsoft Office applications and comfortable learning and working within electronic systems.
Willingness to perform both routine, repetitive, detail-oriented activities and more complex Quality assignments and projects.

Nice To Haves

Bilingual English/Spanish communication skills preferred due to the highly collaborative, hands-on nature of the role within our manufacturing environment.
Experience reading and interpreting engineering drawings and specifications is preferred.
An associate degree, technical training, Quality certification, or equivalent combination of education and relevant hands-on experience is preferred. A bachelor's degree is not required.

Responsibilities

Perform incoming visual and dimensional inspections of components and materials against established specifications and inspection criteria using calipers and other inspection and measurement equipment.
Support final inspection of completed medical imaging systems and associated manufacturing documentation prior to product release.
Maintain day-to-day Quality oversight of nonconforming material and the quarantine area, ensuring items are properly identified, controlled, and associated with appropriate NCR records.
Support the NCR process by monitoring status, gathering information, coordinating follow-up, reviewing records for completeness, and helping facilitate timely resolution and closure.
Work closely with Manufacturing, Engineering, Procurement, Service, and other functions to support resolution of Quality issues.
Support calibration activities, including equipment status tracking, coordination of scheduled calibration activities, review of calibration documentation, and proper equipment identification.
Review manufacturing and Quality records for completeness, accuracy, traceability, and compliance with established procedures, including scanning and reconciliation of physical records as needed.
Provide a regular Quality presence on the manufacturing floor, identifying documentation, workmanship, inspection, or process concerns and working constructively with personnel to address or escalate issues as appropriate.
Support Quality projects, corrective actions, effectiveness checks, audits, and other QMS activities as needed.