Senior Supplier Quality Engineer – Onsite, CAPA Leader

Kindeva; St. Louis (MO); On-site; USD 95,000 - 130,000; Full time

Job summary

Kindeva is seeking a Senior Supplier Quality Engineer to oversee all supplier quality processes, issue evaluation, and corrective actions. You will manage QC records within Change Management, SCAR, and Commitment Tracking, and support data-driven decisions with statistical methods, including Cp/Cpk and design of experiments.

The role requires onsite work in a medical device/pharma environment with strong CAPA, root-cause analysis, and project management skills, plus familiarity with regulatory

Qualifications

• BS in Engineering; minimum 2 years medical device/pharma QA experience.
• Familiar with cGMPs, FDA guidelines, ISO/ASTM standards.
• Certified Quality Engineer or Six Sigma training preferred.

Responsibilities

• Oversee quality issues for suppliers/vendors and drive CAPA.
• Manage Change Management, SCAR, and Commitment Tracking records.
• Design and execute quality engineering protocols and studies.
• Perform data analysis and reporting using control charts and capability studies.
• Coordinate corrective actions and root-cause investigations.

Skills

Quality Engineering

CAPA

Minitab

Root cause analysis

Statistical analysis

Project management

Change management

SCAR

Education

BS in Engineering

2+ years medical device/pharma QA experience

Tools

MINITAB

Job description

Kindeva is seeking a Senior Supplier Quality Engineer to oversee all supplier quality processes, issue evaluation, and corrective actions. You will manage QC records within Change Management, SCAR, and Commitment Tracking, and support data-driven decisions with statistical methods, including Cp/Cpk and design of experiments.

The role requires onsite work in a medical device/pharma environment with strong CAPA, root-cause analysis, and project management skills, plus familiarity with regulatory