Quality Assurance Specialist

About the role

The Quality Assurance Specialist will support Ethicon LLC’s manufacturing operations by ensuring product quality and regulatory compliance. Reporting to the Quality Team Leader, the role focuses on maintaining high standards throughout the production process.

Key responsibilities

• Handle non‑conformant or potentially non‑conformant material, including placement and removal from hold cages.
• Lead stop‑shipment activities and coordinate corrective actions.
• Support cost‑improvement projects at the plant level and prepare related reports.
• Engage in QA operations in accordance with QSR, ISO standards, and Ethicon specifications.
• Maintain the OPCERT program and perform data analysis to drive process improvements.

Required profile

• Experience in a manufacturing quality environment, preferably within medical devices.
• Knowledge of QSR, ISO standards, and regulatory requirements.
• Ability to work with cross‑functional teams and follow documented procedures.

Required skills

• Familiarity with OPCERT program management.
• Data analysis for quality and process improvement.

What we offer

• Opportunity to contribute to innovative MedTech solutions.
• Inclusive work environment that values diversity and individual merit.