Quality Engineer I - Manufacturing

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., 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. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com.

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.

Key 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.

Qualifications

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.
• Strong analytical, problem-solving, and communication skills.

Preferred

• 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.

Knowledge & Skills

• Quality systems and regulatory compliance.
• Risk management and continuous improvement methodologies.
• Ability to manage multiple priorities and work effectively across functions.
• Strong technical writing and documentation skills.

Additional Information

• Occasional travel may be required.
• Ability to work in both office and manufacturing environments.
• Must be able to occasionally lift up to 20 pounds.

Why Join Us?

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.

Salary Range

$85,300 - $95,300

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. 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. Know Your Rights: Workplace Discrimination is Illegal.