B. Braun

Manager II, QA Quality Systems

Job Locations US-CA-Irvine
Requisition ID
2020-17310
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
M-F; 8am - 5pm
Site
Irvine, CA

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 61,000 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:

 

Manage the development, establishment, and  maintenance of Quality systems, policies, processes, procedures and controls ensuring that performance and quality of cGMP documentation and records conforms to established standards.  This position will manage the Change Control, CAPA, Documentation Control, Quality Management Review processes.  The Quality Systems Manager will be responsible for continuous improvement of the Quality Systems in response to business needs, customer audits and regulatory inspections and overall oversight of the systems.

 

Responsibilities: Essential Duties

  • Manages programs and activities within the quality assurance functions of an organization.
  • Administers policies and programs ensuring that organizational products and processes meet established quality standards.
  • Participates in the development, implementation and administration of an organizational quality management system and monitors progress against strategic quality related goals.
  • Manages the work of a team of analysts that collect data identifying potential quality failures, evaluate quality of raw materials or components, in progress goods, processes or operations, and implement and measure the impact of corrective actions.
  • Solicits internal and external feedback with the goal of continuously improving processes or products.
  • Manage the Quality Systems group to ensure that systems and processes are operation in a state of control and in compliance with regulatory requirement and internal SOPs.
  • Support and drive the ongoing implementation of Quality Management Systems
  • Manage the document control function, including issuance and archival of GMP documentation, issuance of production records.  
  • Review and approve corrective and preventive (CAPA) actions and ensure documents are closed in a timely manner.  
  • Manage the CAPA system, ensuring appropriate CAPA are identified and implemented as required.
  • Manage the SOP system to ensure that procedures are current and reflect the intended process.
  • Administer the Change Control program to ensure all changes are appropriately assessed, documented, implemented and closed on time.
  • Develop and track key Quality metrics and KPIs to monitor the performance of the Quality System; perform trend analysis
  • Assist the Head of QA with all customer, third-party and regulatory audits including preparation of responses to audit and inspectional observations.  
  • Responsible for personnel actions including hiring, performance management, termination
 
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
 
General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.

 

Expertise: Knowledge & Skills

  • Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
  • 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.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.

 

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

  • Bachelor's degree required.
  • 08-10 years related experience required.
  • Regular and predictable attendance
  • Occasional business travel required

 

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.

 

 

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.

 

Other

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: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

 

Notices

Equal Opportunity Employer Veterans/Disabled

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