Senior Quality Systems Specialist: Regulatory & CAPA Leader

BD; Franklin Lakes (NJ); Vor Ort; USD 110.000 - 176.000; Vollzeit

Benefits dieser Stelle

Annual Bonus

Health benefits

Zusammenfassung

BD is a leading global medical technology company. The role involves ensuring quality system standards across assigned areas and developing solutions for moderate scope activities. You will work cross-functionally, applying regulatory requirements (FDA 21 CFR 820, ISO 13485) and updating procedures when needed.

Strong knowledge of quality systems and the ability to independently drive solutions is required, with emphasis on CAPA, risk management, and continuous improvement.

Qualifikationen

• Bachelor’s degree in science, engineering, or other relevant discipline.
• Experience with quality systems and regulatory requirements.
• Knowledge of CAPA, risk management, design controls and documentation.

Aufgaben

• Consistent application of quality system standards to assigned quality system area.
• Develops solutions to routine assigned activities of moderate scope & complexity.
• Follows applicable Company/Unit procedures and may update procedures and policies.
• Works within and across functions for assigned quality systems.
• Knowledge of FDA medical device quality system regulations and international standards.

Kenntnisse

Quality Systems

FDA Regulations

CAPA

Risk Management

Training

Ausbildung

Bachelor’s degree in science/engineering or related discipline

Tools

BD software systems

Jobbeschreibung

BD is a leading global medical technology company. The role involves ensuring quality system standards across assigned areas and developing solutions for moderate scope activities. You will work cross-functionally, applying regulatory requirements (FDA 21 CFR 820, ISO 13485) and updating procedures when needed.

Strong knowledge of quality systems and the ability to independently drive solutions is required, with emphasis on CAPA, risk management, and continuous improvement.