Quality Specialist I -Product Release
US-CA-Irvine
Job ID: 2025-25335
Type: Regular Full-Time
# of Openings: 1
Category: Quality
Irvine Facility
Overview
About B. Braun
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.
Responsibilities
Position Summary:
Responsibilities: Essential Duties
- Provide Quality oversight over the Quality System, including but not limited to the review SOPs, protocols, reports, data (including meta data) and records generated to support the manufacturing and distribution of product.
- Conducts timely Quality review of associated data, including data utilized to support batch release, to meet business and operations requirements.
- Assists in complying with regulatory requirements related to product safety and quality.
- Ensures that procedures are being followed as outlined under FDA, ICH, Standard Methods and the Quality System requirements.
- Reviews records to ensure data meets the industry requirements for data integrity.
- Provides input and quality oversight over investigations, which includes review and approve the investigation reports.
- Provides Quality oversight over equipment/software qualification, calibration and validation.
- Partners with Corporate Quality to implement centralized processes and ensures compliance to industry standards and compendial requirements.
Expertise: Knowledge & Skills
- 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.
- 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.
- Judgement is required in resolving all day-to-day problems.
- Contacts are primarily with direct supervisor, peers and subordinates.
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.
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Target Based Range
$83,610 - $104,509
Qualifications
Expertise: Qualifications -Education/Experience/Training/Etc
Required:
- Bachelor's degree required or equivalent combination of education and experience.
- 04-06 years related experience required.
- Applicable industry/professional certification preferred.
- 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.
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Additional Information
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:
While performing the duties of this job, the employee is expected to:
- Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
Lifting, Carrying, Pushing, Pulling and Reaching:
- Occasionally:Reaching upward and downward, Push/pull
- Frequently:Stand, Sit
- Constantly:N/A
Activities:
- Occasionally:Finger feeling, Push/pull, Reaching upward and downward
- Frequently:Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Standing
- Constantly:Hearing - ordinary, fine distinction, loud (hearing protection required), Talking - ordinary, loud/quick
Environmental Conditions:
- Occasionally:N/A
- Frequently:N/A
- Constantly:N/A
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Noise Intensity:Moderate
- Occasionally:Production/manufacturing environment
- Frequently:N/A
- Constantly:Office environment
What We Offer
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.
Notices
Equal Opportunity Employer Veterans/Disabled
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.
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