Quality Lead I

B. Braun US Pharmaceutical Manufacturing LLC; Irvine (CA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical, Inc. in Irvine, CA is seeking a Quality Lead I to provide quality oversight for GMP manufacturing operations, ensuring timely QCRVs and IR handling, and coordinating cross‑functional activities to keep production ready.

The role requires strong knowledge of GMP, documentation practices, and quality systems, with the ability to train Quality Operations Associates and escalate issues to Quality Management. Regular on‑site attendance is required.

Qualifications

• Bachelor’s degree in science, engineering, or related field preferred, or six years in GMP‑regulated environment.
• Experience managing Quality Control Release Verifications (QCRVs) and Incident Reports (IRs).
• Strong understanding of GMP regulations and documentation practices.
• Ability to interpret procedures and conduct investigations across functional areas.
• On‑site attendance required with non‑standard schedules as needed.

Responsibilities

• Perform Quality Control Release Verifications (QCRVs) and process Incident Reports (IRs) to support manufacturing while ensuring GMP compliance.
• Manage QCRV and IR workflows to ensure laboratory testing requirements are identified and completed before room release.
• Review manufacturing docs and quality records to verify completion prior to authorizing release.
• Interpret quality procedures and manufacturing requirements while ensuring regulatory expectations.
• Assist with investigations, gather information, and support corrective actions.

Skills

Quality Assurance

GMP Regulations

Investigations

Documentation

Cross-functional Communication

Education

Bachelor’s degree in science/engineering

Job description

Overview

B. Braun Medical, Inc. is a leader in infusion therapy and pain management. The company develops, manufactures, and markets medical products and services to the healthcare industry, with a focus on patient safety and quality. This position is located in Irvine, California and is an onsite role in the Quality functional area.

Position Summary

The Quality Lead I provides quality oversight and support for manufacturing operations within a GMP-regulated environment. This role ensures timely and compliant execution of Quality Control Release Verifications (QCRVs) and Incident Reports (IRs), coordinating workflows that support manufacturing room release and operational continuity. The Quality Lead I reviews manufacturing and quality documentation, coordinates laboratory testing requirements, investigates quality-related issues, and verifies compliance with internal procedures, GMP regulations, and quality system standards.

Acting as a key liaison between Quality, Manufacturing, Laboratory Operations, Engineering, and other cross-functional teams, the role applies analytical and problem‑solving skills to assess quality risks, resolve operational issues, and support manufacturing readiness. The position provides guidance and training to Quality Operations Associates, supports investigations and corrective actions, and ensures quality concerns are escalated as needed. The role requires advanced knowledge of quality systems, manufacturing processes, documentation practices, and regulatory requirements, with the ability to work independently with a high level of accuracy and attention to detail.

Responsibilities

• Responsible for performing Quality Control Release Verifications (QCRVs) and processing Incident Reports (IRs) to support manufacturing operations while ensuring compliance with applicable procedures, quality standards, and GMP.
• Manage the QCRV and IR workflow to ensure laboratory testing requirements are identified, initiated, tracked, and completed before manufacturing rooms are released back to production.
• Review manufacturing documentation, laboratory testing requirements, and quality records to verify all required activities have been completed prior to authorizing room release.
• Interpret and execute quality procedures, work instructions, and manufacturing requirements while ensuring compliance with internal quality systems and regulatory expectations.
• Perform detailed research using available quality systems, documentation, historical records, and cross-functional resources to investigate issues, identify required actions, and support timely resolution.
• Apply advanced analytical and critical-thinking skills to evaluate complex manufacturing situations, identify potential quality risks, determine appropriate actions, and resolve issues that may impact manufacturing operations.
• Provide quality oversight of manufacturing processes to ensure compliance with established procedures, data integrity requirements, and quality system expectations.
• Coordinate and communicate effectively with laboratory personnel, manufacturing associates, supervisors, managers, engineers, and other cross-functional departments to facilitate testing completion, issue resolution, and manufacturing continuity.
• Provide routine work direction, coaching, and training to Quality Operations Associates regarding quality systems, QCRV processing, IR management, and manufacturing support activities.
• Escalate quality concerns, testing delays, compliance risks, or manufacturing issues to Quality Management as appropriate.
• Support quality investigations by gathering information, reviewing documentation, identifying potential root causes, and assisting with implementation of corrective actions.
• Perform additional quality-related responsibilities as assigned by management to support business objectives and manufacturing operations.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• Bachelor’s degree in a science, engineering, or related technical field preferred.
• Or six years of experience in Quality Assurance, Quality Operations, Manufacturing, Laboratory Operations, or a related GMP-regulated environment.
• Demonstrated experience managing Quality Control and Incident Reports, manufacturing documentation, and quality system workflows.
• Strong understanding of GMP regulations, documentation practices, manufacturing processes, laboratory testing requirements, and quality systems.
• Proven ability to interpret technical procedures, perform investigations, conduct research, and communicate effectively across multiple functional areas.
• Ability to work non-standard schedules as business needs require.
• Regular and predictable on-site attendance.

Schedule: Monday - Friday 9am - 5:30pm

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.