Quality Engineer I: Root Cause & Process Improvement

RXinsider LTD.; Allentown (Lehigh County); On-site; USD 85,000 - 95,000; Full time

Job summary

B. Braun Medical Inc. is seeking a Quality Assurance professional to provide full quality support across materials, products, processes and test methods.

You will manage root-cause analyses, CAPAs and complaint trends, represent QA at MRB meetings, and drive quality improvements that protect production KPIs. You will lead equipment installation, qualification and test method validation activities while collaborating with design, product management and production teams to prevent defects and

Qualifications

• 2-4 years related experience required.
• Bachelor's Degree required.
• Applicable industry/professional certification preferred.
• Occasional business travel required.
• Regular and predictable attendance required.

Responsibilities

• Establish quality standards for products and processes.
• Audit production processes, raw materials or suppliers/vendors.
• Conduct root cause analysis for defects, non conformities or other quality failures.
• May be responsible for ensuring compliance with formal external quality standards such as ISO 9001.
• Lead and participate in quality improvement initiatives and CAPA management.

Skills

Quality Assurance

Root Cause

CAPA

MRB

Risk Assessment

Cross-functional

Method Validation

Equipment Installation

Quality Standards

Education

Bachelor's Degree

Job description

B. Braun Medical Inc. is seeking a Quality Assurance professional to provide full quality support across materials, products, processes and test methods.

You will manage root-cause analyses, CAPAs and complaint trends, represent QA at MRB meetings, and drive quality improvements that protect production KPIs. You will lead equipment installation, qualification and test method validation activities while collaborating with design, product management and production teams to prevent defects and