Principal Quality Engineer, Medtech & Drug Delivery

Socket.dev; Ontario (CA); On-site; USD 170,000 - 230,000; Full time

Job summary

Socket.dev is seeking a Principal Quality Engineer to lead quality systems across Drug Delivery, IVD, and Medtech programs. This role shapes design controls, supplier qualification, and validation strategies for complex molded components and external partners.

You will drive risk management, CAPA, and continuous improvement using Lean and Six Sigma tools, ensuring FDA/ISO compliance and robust product development.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, or Industrial Engineering (advanced degree preferred).
• Minimum 8 years of quality engineering experience in medical devices or combination products.
• Experience managing suppliers of precision-molded components and assemblies.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma Belt preferred.

Responsibilities

• Serve as the technical quality lead for Drug Delivery, IVD and Medtech projects from concept to commercialization.
• Provide quality oversight of external CDMOs and suppliers to ensure regulatory alignment.
• Drive validation strategies (IQ/OQ/PQ) for molded and assembled components.
• Lead root cause investigations and CAPA per FDA 21 CFR Part 820 and ISO 13485.
• Author and review SOPs, validation protocols, and quality plans for DHFs and risk files.

Skills

Quality Engineering

Design Controls

Validation (IQ/OQ/PQ)

Risk Management (pFMEA)

SPC

Root Cause Analysis

Statistical Techniques (Minitab)

Cross-functional Leadership

Education

Bachelor’s degree in Mechanical/Biomedical/Industrial Engineering

CQE/CQA or Six Sigma Belt preferred

Tools

Minitab

Job description

Socket.dev is seeking a Principal Quality Engineer to lead quality systems across Drug Delivery, IVD, and Medtech programs. This role shapes design controls, supplier qualification, and validation strategies for complex molded components and external partners.

You will drive risk management, CAPA, and continuous improvement using Lean and Six Sigma tools, ensuring FDA/ISO compliance and robust product development.