QC Technician – Medical Devices, GMP & ISO 13485

SHL Medical AG; Deerfield Beach (FL); On-site; USD 54,000 - 76,000; Full time

Benefits offered by this job

Competitive compensation

Modern facilities

Professional development

Job summary

SHL Medical is seeking a QC Technician to support Operations by inspecting materials, testing devices, and reviewing QC data for release decisions. You will work closely with Warehouse, Supply Chain, and Manufacturing to ensure quality across the product lifecycle.

The role requires 2–4 years in testing equipment setup and 2+ years in quality control, with strong ISO 13485/GMP/FDA CAPA and GDP/cGMP knowledge. Competitive benefits and a dynamic global team are offered.

Qualifications

• 2–4 years’ experience in testing equipment setup, maintenance, and troubleshooting.
• At least 2 years in quality control using inspection tools.
• Advanced knowledge of ISO 13485, GMP, FDA compliance, CAPA, and risk management.
• Experience with quality investigations preferred.
• Knowledge of sampling plans.
• GDP knowledge.
• cGMP knowledge.
• Proficient with Microsoft Word, Teams, Excel, PowerPoint, PLM systems and SAP.

Responsibilities

• Review QC-generated testing and inspection data.
• Provide technical training.
• Assist other departments with validation plans impacting QC.
• Perform quality activities to support the Product manufacturing process.
• Inspect incoming materials, in-process materials and finished products per procedures.
• Perform device testing and visual inspections for product realization, stability studies, and validations.
• Notify management of nonconforming material or test failures.
• Perform product identification and traceability activities.
• Initiate and assist Nonconformance reports investigations, and corrective actions.
• Initiate and assist with document updates (QOP, QWI, and TS).
• Comply with quality, safety, and work rules and regulations.
• Must be flexible to work a variety of schedules to meet business needs.
• Perform other related duties as assigned.

Skills

Testing equipment setup

Quality control

Regulatory compliance

Quality investigations

Sampling plans

GDP knowledge

cGMP knowledge

MS Office & SAP

Tools

SAP

PLM Systems

Job description

SHL Medical is seeking a QC Technician to support Operations by inspecting materials, testing devices, and reviewing QC data for release decisions. You will work closely with Warehouse, Supply Chain, and Manufacturing to ensure quality across the product lifecycle.

The role requires 2–4 years in testing equipment setup and 2+ years in quality control, with strong ISO 13485/GMP/FDA CAPA and GDP/cGMP knowledge. Competitive benefits and a dynamic global team are offered.