Quality Assurance / Quality Control Specialist

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.

• 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.

• 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.

• Competitive compensation based on experience
• PTO package and paid holidays
• 401(k) with Safe Harbor company match
• Tuition reimbursement
• Medical, dental, vision, disability, and life insurance
• HSA with employer match contribution