Quality Systems Analyst

Position: Quality Systems Analyst I
Job Description You're an important part of our future. Hopefully, we're also a part of your future! At

B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That's why we would like to keep developing our company with you. Keeping your future in mind, we're making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise. Quality Systems Analyst I Company:

B. Braun US Pharmaceutical Manufacturing LLC Job Posting

Location:

Daytona Beach, Florida, United States

Functional Area:

Quality Working Model:
Onsite Days of Work:
Wednesday, Tuesday, Thursday, Friday, Monday

Shift: 5X8 Relocation Available:
No

Requisition  

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

Position Summary:

The Quality Analyst I supports the Quality Assurance team by maintaining and improving quality systems in compliance with regulatory and company requirements. This role is ideal for an early‑career quality professional with hands‑on experience or strong exposure to quality systems, documentation, and regulated manufacturing environments. The Quality Analyst I will assist with activities related to document control, deviations, CAPAs, change management, and audits, while ensuring compliance with applicable GMP, FDA, and ISO standards.

Responsibilities:
Essential Duties *

Quality System Management
* Maintain and monitor QMS elements including document control, training records, CAPAs, deviations, and change controls
* Ensure timely review, approval, and archival of controlled documents in accordance with GDP
* Support the implementation and continuous improvement of electronic quality systems (e.g., Track Wise)
* Data Analysis & Reporting
* Analyze quality metrics and trends to identify areas for improvement
* Generate reports for management review, audits, and regulatory inspections
* Track and follow up on open quality events to ensure timely closure
* Audit & Compliance Support
* Assist in internal and external audits by preparing documentation and responding to findings
* Ensure compliance with FDA, and other applicable regulatory standards
* Support audit readiness and inspection preparedness activities
* Cross-Functional Collaboration
* Work closely with QA, manufacturing, regulatory, and QC teams to resolve quality system issues
* Provide training and guidance to users on QMS processes and tools
* Participate in quality improvement initiatives and system upgrades The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. Expertise:
Knowledge & Skills
* Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning & checking the work of other peers.
* Requires basic knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
* Some degree of judgment required in resolving problems based on experience.
* Contacts are primarily with department supervisors, leads, subordinates, and…