Quality Engineer I — CAPA, Risk & Continuous Improvement

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

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. in Bethlehem, PA, is seeking a Quality Engineer I to provide quality support, ensure compliance, and drive continuous improvement.

You will lead investigations, CAPAs, risk assessments, and validation activities while partnering with cross-functional teams to resolve quality issues and improve processes. The role requires a bachelor’s degree in engineering or life sciences, 2+ years in quality-related fields, and strong analytical and communication skills.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field.
• 2+ years of experience in Quality Engineering, Quality Assurance, Manufacturing, or a related field.
• Experience with root cause analysis, investigations, and CAPA management.
• Strong analytical, problem-solving, and communication skills.

Responsibilities

• Lead root cause investigations for nonconformances, complaints, and quality events.
• Manage CAPAs, change controls, and quality improvement initiatives.
• Serve as the Quality representative for MRB meetings.
• Conduct risk assessments and develop mitigation plans to support Quality and Production KPIs.
• Support equipment qualification, installation, and test method validation activities.
• Audit manufacturing processes, suppliers, and raw materials to ensure quality standards.
• Collaborate with Engineering, Manufacturing, and Operations teams to identify and mitigate quality risks.
• Analyze quality data and complaint trends to drive continuous improvement.

Skills

Root cause analysis

Analytical skills

Problem solving

Communication skills

Education

Bachelor's degree in Engineering, Quality, Life Sciences, or related technical field

Tools

ASQ

Six Sigma

Job description

B. Braun Medical Inc. in Bethlehem, PA, is seeking a Quality Engineer I to provide quality support, ensure compliance, and drive continuous improvement.

You will lead investigations, CAPAs, risk assessments, and validation activities while partnering with cross-functional teams to resolve quality issues and improve processes. The role requires a bachelor’s degree in engineering or life sciences, 2+ years in quality-related fields, and strong analytical and communication skills.