Sr. Quality Engineer

B. Braun US Device Manufacturing LLC; Carrollton (TX); On-site; USD 105,000 - 115,000; Full time

Job summary

B. Braun US Device Manufacturing LLC in Carrollton, TX is seeking a Senior Quality Engineer to strengthen the Quality Management System and drive process improvements.

The role partners with cross-functional teams to ensure regulatory compliance and to advance product quality and patient safety. Eligible candidates will have a bachelor’s degree in a related field, 6+ years in quality engineering within a regulated manufacturing environment, and professional ASQ CQE/CQA certification or

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related field.
• 6+ years of Quality Engineering experience in a regulated manufacturing environment.
• Medical Device industry experience required.
• Professional quality certification (ASQ CQE, CQA, or equivalent).
• Strong knowledge of Quality Management Systems (QMS), CAPA, Root Cause Analysis, Change Control, Validation, Internal Auditing, Complaint Handling.

Responsibilities

• Lead and support quality system activities, including: Nonconformances, CAPA investigations, Complaint investigations and trend analysis, Change control, Validation activities, Quality inspections, MRB activities, Internal audits.
• Conduct root cause investigations and implement effective corrective actions.
• Collaborate with Engineering, Manufacturing, and other teams to identify and mitigate quality risks.
• Ensure compliance with FDA regulations, ISO 13485, and internal quality standards.
• Audit processes, suppliers, and materials to ensure quality requirements are met.
• Drive continuous improvement and quality enhancement projects.
• Analyze quality data and recommend process improvements.

Skills

Quality Management Systems (QMS)

CAPA

Root Cause Analysis

Change Control

Validation

Internal Auditing

Complaint Handling

Education

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

Tools

SAP

Job description

B. Braun Medical, Inc.

Company: B. Braun US Device Manufacturing LLC

Job Posting Location: Carrollton, Texas, United States

Functional Area: Quality

Working Model: Onsite

Days of Work: Wednesday, Tuesday, Friday, Thursday, Monday

Shift: 5X8

Relocation Available: No

Requisition ID: 13418

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

Senior Quality Engineer

Location: Carrollton, TX

Make a Difference in Quality and Patient Safety

We are seeking a Senior Quality Engineer with medical device industry experience to support and continuously improve our Quality Management System (QMS). In this role, you will partner with cross-functional teams to ensure compliance, drive quality excellence, and lead process improvement initiatives that support safe and effective products.

Key Responsibilities

• Lead and support quality system activities, including:
  • Nonconformances
  • CAPA investigations
  • Complaint investigations and trend analysis
  • Change control
  • Validation activities
  • Quality inspections
  • Material Review Board (MRB) activities
  • Internal audits
• Conduct root cause investigations and implement effective corrective actions.
• Collaborate with Engineering, Manufacturing, and other teams to identify and mitigate quality risks.
• Ensure compliance with FDA regulations, ISO 13485, and internal quality standards.
• Audit processes, suppliers, and materials to ensure quality requirements are met.
• Drive continuous improvement and quality enhancement projects.
• Analyze quality data and recommend process improvements.

Required Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related field.
• 6+ years of Quality Engineering experience in a regulated manufacturing environment.
• Medical Device industry experience required.
• Professional quality certification (ASQ CQE, CQA, or equivalent).
• Strong knowledge of:
  • Quality Management Systems (QMS)
  • CAPA
  • Root Cause Analysis
  • Change Control
  • Validation
  • Internal Auditing
  • Complaint Handling

Preferred Qualifications

• Master's degree.
• Experience with SAP.
• Experience leading projects, teams, or continuous improvement initiatives.
• Knowledge of Lean Manufacturing or Six Sigma methodologies.
• Experience supporting regulatory audits and inspections.

Additional Information

• Ability to work non-standard hours as needed to support business objectives.
• Commitment to maintaining a safe work environment and following all company safety policies.
• Must be able to perform the essential functions of the position with or without reasonable accommodation.

Salary Range: $105,300 - $115,300

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, click here.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Equal employment opportunity, including veterans and individuals with disabilities.

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