Quality Assurance / Quality Control Specialist

Omega Medical Imaging LLC

Sanford (FL)

On-site

USD 65,000 - 90,000

Full time

36 hours ago

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Benefits offered by this job

PTO & Holidays

401(k) with Safe Harbor

Tuition reimbursement

Health insurance

HSA with employer match

Job summary

Omega Medical Imaging seeks a hands-on Quality Assurance / Quality Control Specialist to support day-to-day manufacturing quality on-site in Sanford, Florida. This role concentrates on physical inspections, NCR handling, calibration support, and quality records, collaborating with Manufacturing, Engineering, and Service teams.

The ideal candidate brings 3+ years in FDA/ISO-regulated medical device QA/QC, attention to detail, and the ability to drive timely NCR resolution while maintaining

Qualifications

Hands-on QA/QC experience in FDA/ISO manufacturing environments.
Experience with nonconforming material/NCRs and calibration workflows.
Strong attention to detail, documentation, and traceability.

Responsibilities

Perform incoming visual and dimensional inspections with calipers and measurement tools.
Support final inspection and product release documentation.
Maintain NCR records and quarantine area for nonconforming materials.
Coordinate NCR follow-ups and closure with cross-functional teams.
Assist calibration activities and review calibration docs.
Review manufacturing and quality records for accuracy and traceability.
Provide regular on-floor quality presence and address issues constructively.
Contribute to quality projects, audits, and corrective actions.

Skills

Quality Assurance

Quality Control

FDA-regulated

English proficiency

Education

Associate degree

Quality certification

Technical training

Tools

Microsoft Office

Job description

About Omega Medical Imaging

At Omega Medical Imaging, we are innovators in the field of interventional imaging. As the only company in the world specializing in AI-driven fluoroscopy systems for Cardiology and Gastrointestinal cases, we're transforming how clinicians perform life-saving procedures. Our FluoroShield technology reduces radiation exposure by up to 84%, enhancing patient safety and improving clinical outcomes.

Omega Medical Imaging - Sanford, FL

Full-Time | On-Site

About Omega Medical Imaging

Joining Omega Medical Imaging means being part of a mission-driven team where your work has a measurable impact on healthcare delivery - and where your technical expertise directly supports our commitment to excellence, innovation, and service.

Position Overview

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.

What This Role Is - And Is Not

This is a hands-on manufacturing Quality role focused on physical products and components. The position involves mechanical and visual inspection, use of measurement tools such as calipers, nonconforming material control, and regular work on the manufacturing floor.

This is not a Regulatory Affairs position, software QA/testing role, or laboratory/wet chemistry QC position. Candidates should be interested in hands-on Quality work involving mechanical components, assemblies, manufacturing processes, and physical inspections.

What You'll Do

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 elevate issues as appropriate.
Support Quality projects, corrective actions, effectiveness checks, audits, and other QMS activities as needed.

What We're Looking For

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.
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

The Person Who Will Thrive In This Role

You are methodical, organized, mechanically inclined, and exceptionally detail-oriented. You enjoy being close to the work and are comfortable moving between the manufacturing floor and Quality records throughout the day. You understand that seemingly small activities (e.g. checking a measurement, reconciling a record, following up on an open NCR, or making sure an item is properly controlled) matter in a regulated medical device environment.

You have the confidence to speak up when something doesn't look right, but you approach Quality as a collaborative function rather than a policing function. You seek first to understand, ask thoughtful questions, and work with others to determine the appropriate path forward. You don't overlook an issue because addressing it may be inconvenient, but you also understand that effective Quality requires judgment, communication, and collaboration.

You are comfortable working within established processes and direction while priorities continue to evolve. You can adapt and pivot when needed, take ownership of your commitments, and understand that Quality sets the example by consistently following the processes we expect others to follow.

Position Type

Full-time, on-site position in Sanford, Florida. This role will spend a significant portion of the workday within Omega's manufacturing and inspection areas and requires regular interaction with manufactured components, production equipment, inspection tools, and completed medical imaging systems.

What We Offer