Principal Quality Engineer - Medtech & Drug Delivery

Stevanato Group; Ontario (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Stevanato Group in California is seeking a Principal Quality Engineer to lead quality systems development across drug delivery, IVD, and Medtech projects. You will act as SME for regulatory compliance and risk management, guiding design transfer and validation strategies.

This role focuses on supplier quality, CAPA, and continuous improvement, with leadership to drive Lean/Six Sigma initiatives and ensure FDA 21 CFR 820 and ISO 13485 alignment.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, or Industrial Engineering; advanced degree preferred.
• CQE/CQA or Six Sigma Black/Green Belt preferred.
• Proficiency in Minitab and statistical techniques for validation and quality control.

Responsibilities

• Lead quality engineering for Drug Delivery, IVD and Medtech platform projects.
• Drive process validation strategies (IQ/OQ/PQ) for molded and assembled components.
• Oversee supplier quality, audits, and control of external partners.
• Lead CAPA investigations and ensure closure per FDA 21 CFR Part 820 and ISO 13485.
• Develop control plans, pFMEAs, and inspection documentation.

Skills

Quality engineering

Regulatory compliance

Lean Six Sigma

GR&R

IQ/OQ/PQ

SPC

Root cause analysis

Design controls

Supplier quality

Analytical thinking

Education

Bachelor's degree in Mechanical, Biomedical, or Industrial Engineering

CQE/CQA or Six Sigma certification preferred

Tools

Minitab

Job description

Stevanato Group in California is seeking a Principal Quality Engineer to lead quality systems development across drug delivery, IVD, and Medtech projects. You will act as SME for regulatory compliance and risk management, guiding design transfer and validation strategies.

This role focuses on supplier quality, CAPA, and continuous improvement, with leadership to drive Lean/Six Sigma initiatives and ensure FDA 21 CFR 820 and ISO 13485 alignment.