Quality Systems Analyst I

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., TrackWise)  
  • 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 peers. Occasional contact with external contractors/vendors.

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• Bachelor's degree required or equivalent combination of education and experience.
• 02-04 years related experience required. Pharma experience preferred.
• Occasional business travel required, Ability to work non-standard schedule as needed.
• Regular and predictable attendance.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

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 .

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 .