Manufacturing quality engineering

Quality Engineer I - Manufacturing

Braun US Device Manufacturing LLC

Functional Area: Quality

Shift: 5X8

Relocation Available: No

Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. Braun Medical is headquartered in Bethlehem, Pa., Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. Braun Medical, visit
Position Summary The Quality Engineer I provides quality support to ensure compliance, product quality, and continuous improvement. This role leads investigations, CAPAs, complaint trend analysis, risk assessments, and validation activities while partnering with cross-functional teams to resolve quality issues and improve processes.
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.

Required 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.
Experience in a regulated industry (medical device, pharmaceutical, or manufacturing).
Experience with root cause analysis, nonconformance, and change control processes.
ASQ, Six Sigma, or other quality-related certifications.
Quality systems and regulatory compliance.
Risk management and continuous improvement methodologies.
Strong technical writing and documentation skills.
Occasional travel may be required.
Ability to work in both office and manufacturing environments.
Join a collaborative team where you'll have the opportunity to solve complex quality challenges, drive continuous improvement, and make a direct impact on product quality and customer satisfaction.

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; experience and training; Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic.