Quality Engineer I - CAPA & Investigations

B. Braun Group; 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 US Device Manufacturing LLC in Allentown, PA, is hiring a Quality Engineer I - Manufacturing to support quality processes and continuous improvement. You will lead investigations, CAPAs, risk assessments, and validation activities while collaborating with cross-functional teams.

The role requires a bachelor’s degree in a technical field and 2+ years in quality-related roles; on-site work is required, with occasional travel. Salary range is disclosed above.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related field.
• 2+ years in Quality Engineering, QA, Manufacturing, or 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 Material Review Board (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 are met.
• 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

CAPA management

Analytical skills

Communication

Education

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

Job description

B. Braun US Device Manufacturing LLC in Allentown, PA, is hiring a Quality Engineer I - Manufacturing to support quality processes and continuous improvement. You will lead investigations, CAPAs, risk assessments, and validation activities while collaborating with cross-functional teams.

The role requires a bachelor’s degree in a technical field and 2+ years in quality-related roles; on-site work is required, with occasional travel. Salary range is disclosed above.