Senior Quality Engineer - Medical Device Compliance

Becton, Dickinson and Company (BD); San Diego (CA); Vor Ort; USD 106.000 - 169.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) plan

Paid time off

Parental leave

Educational assistance

Zusammenfassung

BD (Becton, Dickinson and Company) seeks a Senior Quality Engineer to support new product development and product maintenance for medical devices, ensuring compliance with design controls and regulatory requirements. You will lead CAPA activities, mentor teams, and collaborate across functions to drive quality improvements.

Required is a Bachelor's degree with at least 7 years' experience in medical device quality engineering, familiarity with 21 CFR 820, ISO 13485, and MDR, and strong

Qualifikationen

• Bachelor’s degree required; 7+ years of medical device quality experience.
• Experience with design assurance and regulatory standards (21 CFR 820, ISO 13485, MDR).
• Asq certifications desirable but not required.

Aufgaben

• Mentor team on quality principles and CAPA.
• Support design control and process validation projects.
• Assist audits and continuous improvement initiatives.
• Collaborate with cross-functional teams to ensure compliance.

Kenntnisse

Quality engineering

CAPA expert

Design control

Regulatory knowledge

Leadership

Ausbildung

Bachelor’s Degree

Jobbeschreibung

BD (Becton, Dickinson and Company) seeks a Senior Quality Engineer to support new product development and product maintenance for medical devices, ensuring compliance with design controls and regulatory requirements. You will lead CAPA activities, mentor teams, and collaborate across functions to drive quality improvements.

Required is a Bachelor's degree with at least 7 years' experience in medical device quality engineering, familiarity with 21 CFR 820, ISO 13485, and MDR, and strong