QC Technician — Quality Inspections & Data Review

SHL Medical AG; Deerfield Beach (FL); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive compensation package

Modern facilities and technologies

Challenging assignments in fast growth

Job summary

SHL Medical AG in Florida seeks a QC Technician to support operations and development by inspecting materials and reviewing testing data. You will work closely with Warehouse, Supply Chain and Manufacturing to ensure product quality and compliance.

The role requires hands-on testing, documentation and adherence to ISO 13485, GMP and GDP standards, with opportunities to train others and contribute to CAPA investigations and process improvements.

Qualifications

• Bachelor’s degree in Science or equivalent experience.
• 2–4 years’ experience in testing equipment set-up, maintenance and troubleshooting.
• Minimum 2 years of experience in quality control, using inspection tools.
• Advanced knowledge of ISO 13485, GMP, FDA compliance, CAPA, and risk management.
• Experience with quality investigations preferred.
• Knowledge and experience with sampling plans.
• Knowledge of Good Documentation Practices (GDP).
• Knowledge of Good Manufacturing Practices (cGMP).
• Proficient in Microsoft Office products; experience with PLM systems and SAP.

Responsibilities

• Performs review of QC-generated testing and inspection data.
• Performs technical training.
• Assists other departments with the development of validation plans impacting QC.
• Performs quality activities to support the Product manufacturing process.
• Inspects incoming materials, in-process materials and finished products per applicable procedures, protocols and/or batch record requirements.
• Performs device testing and visual inspections in support of product realization, stability studies, and validations.
• Notifies management of nonconforming material or test failures in a timely manner.
• Performs product identification and traceability activities as required (e.g. Quarantine).
• Initiates and assists in the Nonconformance reports investigations, and implementation of corrective actions.
• Initiates and assists with document updates (QOP, QWI, and TS).
• Complies with all 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 inspection

ISO 13485 knowledge

GMP & FDA compliance

CAPA & risk management

Quality investigations

Sampling plans

GDP knowledge

cGMP knowledge

Microsoft Office, PLM, SAP

Education

Bachelor’s Degree in Science

Tools

Microsoft Office (Word/Excel/PowerPoint)

PLM Systems

SAP

Job description

SHL Medical AG in Florida seeks a QC Technician to support operations and development by inspecting materials and reviewing testing data. You will work closely with Warehouse, Supply Chain and Manufacturing to ensure product quality and compliance.

The role requires hands-on testing, documentation and adherence to ISO 13485, GMP and GDP standards, with opportunities to train others and contribute to CAPA investigations and process improvements.