B. Braun

Quality Complianc Auditing Spc

Job Locations US-PA-Allentown | US-PA-Allentown
Requisition ID
2021-19328
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
8-5
Site
Allentown, PA

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:

 

Responsible for delivering audit services to support Quality Operations in accordance with all BBMI process and procedures, regulatory requirements to assure timely, effective audit service and delivery that assures satisfaction of our customer regulatory compliance needs and requirements. Able to manage, deliver and implement new initiatives for emerging business and regulatory standards impact to BBMI business value chains. The ideal candidate must have working knowledge of with cGxPs as well as ISO, ICH and USPs and applicable regulations.

 

Responsibilities: Essential Duties

  • Assures quality systems are in compliance to national and international guidelines, standards and regulations.
  • Maintains and continuously improves B. Braun's Quality Management System.
  • Establishes new or improves existing infrastructure to achieve conformance to the ISO 13485, ISO 9001 requirements, the cGMP QS Regulation as well as FDA's new auditing techniques.
  • Follows-up on all Corrective and Preventive Action (CAPA) and to make sure that the datelines will be met.
  • Plans and executes Customer and/or Third Party Audit
  • Plans and executes the whole internal quality audit (IQA) activities from start to end.
  • Prepares Auditor History Log and Qualified Auditors List on yearly basis.
  • Follows-up on audit findings for internal and external audits and regular update of IQA database.
  • Coordinates and maintains the Supplier Audit Process together with Supply Chain Management (SCM).

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 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.
  • Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

 

Required:

  • Bachelor's degree required, Master's degree preferred.
  • 08-10 years related experience required.
  • Applicable industry/professional certification required.
  • Frequent business travel required, Valid driver's license and passport, Secrecy and invention agreement and non- compete agreement, Ability to work non-standard schedule as needed.
  • 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.

 

 

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:

 

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:Reaching upward and downward, Push/pull, Stand, Visual Acuity with or without corrective lenses
  • Frequently: Sit
  • Constantly: N/A

Activities:

  • Occasionally: Finger feeling, Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing, Walking
  • Frequently: Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Talking - ordinary, loud/quick
  • Constantly: N/A

Environmental Conditions:

  • Occasionally: Proximity to moving parts, Exposure to toxic or caustic chemicals (in most areas)
  • 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: N/A
  • Frequently: N/A
  • Constantly: Office environment

Notices

Equal Opportunity Employer Veterans/Disabled

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