Senior Quality Engineer MedTech Product Launch

Regulatory Jobs; San Diego (CA); Vor Ort; USD 130.000 - 207.000; Vollzeit

Zusammenfassung

BD (Becton, Dickinson and Company) seeks a quality engineer in San Diego to support development and maintenance of medical devices through rigorous quality engineering practices. You will work with design control, risk management, and cross‑functional teams to ensure compliance with regulatory requirements and product quality.

The role involves root cause analysis, CAPA investigations, and collaboration with manufacturing, regulatory affairs, and suppliers.

Qualifikationen

• Master’s degree in Engineering (any) or related field and 2 years of experience or a Bachelor’s degree with 5 years of experience.
• Experience with FDA/ISO design controls, risk management, and quality tools.
• Proficiency in technical data analysis and verification/validation approaches.

Aufgaben

• Support new product development and maintenance through quality engineering for medical devices.
• Participate in design control meetings and provide feedback on product quality.
• Coordinate investigations, CAPAs, and corrective actions with cross‑functional teams.
• Prepare reports and assist FDA inspections and internal audits.

Kenntnisse

Statistical analysis

Quality tools

Design controls

FMEA

SPC

Root Cause Analysis

CAPA investigations

Ausbildung

Master’s degree in Engineering (any) or related field

Bachelor’s degree in Engineering (any) or related field

Tools

TeamCenter

Polarion

AzureDevOps

Jobbeschreibung

BD (Becton, Dickinson and Company) seeks a quality engineer in San Diego to support development and maintenance of medical devices through rigorous quality engineering practices. You will work with design control, risk management, and cross‑functional teams to ensure compliance with regulatory requirements and product quality.

The role involves root cause analysis, CAPA investigations, and collaboration with manufacturing, regulatory affairs, and suppliers.