Quality Assurance Engineer I – Root Cause & CAPA Lead

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 in Bethlehem, PA area to provide QA support, perform root cause analyses, and drive CAPA and MRB processes.

The role involves working with design, production and supplier quality to uphold ISO 9001 standards and ensure product quality and compliance. You will lead equipment installation, qualification, and test method validation activities, with travel as needed and a focus on reducing defects and improving process controls.

Qualifications

• 2-4 years related experience required.
• Bachelor's Degree required.
• Occasional business travel required.
• Attendance Regular and predictable attendance.

Responsibilities

• Establishes quality standards for products and processes and suggests modifications to prevent defects.
• Works with design, management and production to mitigate quality risks.
• Audits production processes, raw materials or suppliers to ensure standards are met.
• Conducts root cause analysis for defects and non-conformities.

Skills

Quality Assurance

Root Cause Analysis

CAPA

Risk Assessment

Cross-functional Collaboration

Documentation

Education

Bachelor's Degree

Job description

B. Braun Medical Inc. is seeking a Quality Assurance professional in Bethlehem, PA area to provide QA support, perform root cause analyses, and drive CAPA and MRB processes.

The role involves working with design, production and supplier quality to uphold ISO 9001 standards and ensure product quality and compliance. You will lead equipment installation, qualification, and test method validation activities, with travel as needed and a focus on reducing defects and improving process controls.