B. Braun Medical, Inc.
Associate Director, Quality Assurance
US-CA-Irvine
Job ID: 2024-25120
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:
Direct the site Quality Assurance (QA) organization and manage staff of QA professionals. Assure effective execution of the site quality management system and provide Quality Assurance expertise, oversight and support for manufacturing, investigations of quality events, quality data trending and analysis, CAPA, audit management, risk management, field action management, and change control. Site Subject Matter Expert on Quality Assurance, Quality Systems and Quality Compliance best practices and technologies for pharmaceutical manufacturing and provide technical and tactical support for the site to ensure compliance with regulatory requirements and expectations. Interact with FDA and other regulatory authorities as Subject Matter Expert for site Quality Assurance processes and procedures. Manage the development and implementation of related programs to maximize efficiencies of staff and budgetary resources necessary to support the company goals while assuring compliance with regulatory requirements. Operate in accordance with company policies and procedures, FDA Regulations, ISO Standards, EU and Canadian Regulations, where applicable.
Responsibilities: Essential Duties
- Responsible for all quality functions within organization.
- Develops and implements strategies for ensuring that organizational products and processes meet established quality standards.
- Establishes or administers an organizational quality management system and monitors progress against strategic quality-related goals.
- Identifies potential quality failures, establishes methods for evaluating quality of raw materials or components, in-progress goods, processes or operations and oversees development and implementation of corrective actions.
- Solicits internal and external feedback with the goal of continuously improving processes or products.
- May represent the organization during external inspections or audits.
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
- Requires breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.
- Manages activities of a functional area which has at least 2 departments or major functions through managers and/or experienced employees. Responsible for cost, method, and employee results.
- Judgement is required in resolving complex problems based on experience.
- Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.
- Ability to make verbal presentations to both small and large groups at a variety of levels both inside and outside of the company.
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
$143.809 - $179.756
Qualifications
Expertise: Qualifications - Experience/Training/Education/Etc
Required:
- Bachelor's degree required, Master's degree preferred.
- 10-12 years related experience required.
- Occasional business travel required, Valid driver's license and passport.
- Regular and predictable attendance.
Desired:
- N/A
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:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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:N/A
- Frequently: Stand, Sit
- Constantly: N/A
Activities:
- Occasionally: N/A\
- Frequently: Sitting , Standing, Talking - ordinary, loud/quick, Walking
- Constantly: N/A
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: Low
- Occasionally: Production/manufacturing environment, Warehouse environment, Lab 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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