Senior Quality Engineer, MedTech Design Controls

Becton Dickinson; San Diego (CA); On-site; USD 137,000 - 169,000; Full time

Job summary

BD, Becton, Dickinson and Company, is a global medical technology leader turning health care into better outcomes. This role serves as core team quality representative for design control projects, managing quality planning, verification and validation, risk management and regulatory support to enable product releases in defined markets.

You will review design artifacts for compliance, drive root-cause analysis, ensure traceability of DHFs, and collaborate with cross-functional teams to improve

Qualifications

• Bachelor’s degree in Engineering or related field and 3 years in quality-related roles.
• Experience with quality engineering policies, regulatory standards and risk management.
• Knowledge of software verification, validation and SAFe/agile practices.

Responsibilities

• Manage all quality aspects of the design control process including planning, V&V, risk management and regulatory support.
• Review design artifacts for compliance with QMS and good documentation practices.
• Collaborate with program managers to ensure traceability and timely product release.
• Drive root cause analysis of failures and continuous improvement across development and manufacturing.
• Maintain complete and auditable Design History Files and support cross-functional teams.

Skills

Quality engineering policies

Regulatory standards knowledge

Root cause analysis

Risk management

Software verification & validation

SAFe / Agile

Statistics / sampling

Education

Bachelor’s degree in Engineering or related field

Tools

Sampling Plans

Root Cause Analysis tools

Statistics software

Job description

BD, Becton, Dickinson and Company, is a global medical technology leader turning health care into better outcomes. This role serves as core team quality representative for design control projects, managing quality planning, verification and validation, risk management and regulatory support to enable product releases in defined markets.

You will review design artifacts for compliance, drive root-cause analysis, ensure traceability of DHFs, and collaborate with cross-functional teams to improve