Quality Specialist I

B. Braun Medical Inc. (US); Irvine (CA); On-site; USD 90,000 - 107,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. is seeking a Quality Specialist I to support manufacturing operations and ensure products meet regulatory and quality standards.

The role reviews documentation, investigates issues, and maintains internal quality systems in a hands-on capacity. Responsibilities include overseeing deviations, CAPAs, data integrity, and equipment qualification, while collaborating with cross-functional teams in an onsite setting.

Qualifications

• Bachelor’s degree or equivalent experience in a related field.
• 4+ years of quality, manufacturing, or regulated environment experience.
• Understanding of GMP/regulatory requirements and data integrity principles preferred.

Responsibilities

• Review SOPs, protocols, reports and batch records to support manufacturing and product release.
• Review data (including metadata) to ensure accuracy, completeness and data integrity.
• Support deviations, investigations, and CAPAs, including review of reports.
• Ensure compliance with FDA, ICH and internal quality standards.
• Provide oversight for equipment and software qualification, validation and calibration activities.
• Partner with quality and cross-functional teams to maintain compliance and standardized processes.

Skills

GMP knowledge

Data integrity

Attention to detail

Problem solving

Independent work

Education

Bachelor’s degree or equivalent in related field

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 Specialist I provides hands-on quality support to manufacturing operations, ensuring products meet regulatory, safety, and quality standards. This role is responsible for reviewing documentation, supporting investigations, and maintaining compliance with internal quality systems and industry requirements.

Key Responsibilities

• Review SOPs, protocols, reports, and batch records to support manufacturing and product release
• Review data (including metadata) to ensure accuracy, completeness, and data integrity
• Support deviations, investigations, and CAPAs, including review of reports
• Ensure compliance with FDA, ICH, and internal quality standards
• Provide oversight for equipment and software qualification, validation, and calibration activities
• Partner with quality and cross-functional teams to maintain compliance and standardized processes

Qualifications

• Bachelor’s degree or equivalent experience in a related field
• 4+ years of experience in quality, manufacturing, or a regulated environment
• Understanding of GMP/regulatory requirements and data integrity principles preferred
• Strong attention to detail and problem-solving skills
• Ability to work independently and manage priorities

Work Environment

• Primarily office-based with some time in a manufacturing environment
• Moderate noise levels in production areas
• Regular sitting, standing, and use of hands
• Ability to lift up to 20 lbs occasionally

Schedule: Onsite M-F 8am to 5pm

Pay Rate- $90,000- $107,000 annually

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.