Sr. Quality Engineer

RXinsider LTD.; Carrollton (TX); On-site; USD 105,000 - 115,000; Full time

Benefits offered by this job

Healthcare

401(k)

Tuition reimbursement

Job summary

B. Braun Medical Inc. in Carrollton, TX is seeking a Senior Quality Engineer to lead quality system activities and investigations.

The role requires expertise in CAPA, root cause analysis, change control, and validation to ensure FDA and ISO 13485 compliance. Ideal candidates have 6+ years in quality engineering, medical device experience, and ASQ CQE/CQA or equivalent certification. The position involves collaboration with engineering, manufacturing, and suppliers to drive improvements and

Qualifications

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

Responsibilities

• Lead and support quality system activities including Nonconformances, CAPA investigations, complaints investigations and trend analysis, change control, validation activities, quality inspections, MRB activities, and 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

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., 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

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

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.