B. Braun

Sr. Quality Systems Specialist

Job Locations US-PA-Allentown
Requisition ID
2021-18447
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
8:00 AM - 5:00 PM
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 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:

 

Responsibilities: Essential Duties

  • Administrates, facilitates and maintains site quality management systems to ensure they are efficient, effective and compliant to applicable cGMP, regulatory requirements and expectations, and the Company’s Quality System policies and procedures.
  • Supports regulatory inspections, customer and/or Third Party Audit.
  • Provide direction, training, and mentoring for company personnel on policies in compliance with current GMP’s and corporate policy.
  • Ensuring that the quality system standards imposed by customers are not overlooked, yet do not compromise or conflict with internal B. Braun Requirements.
  • Understands and ensures regulatory compliance.
  • Senior level acts as team leaders for assigned employees (specialists, analysts, administrators, etc).  
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.
  • Provides direct or indirect supervision to a group of employees, assigning tasks and checking work at frequent intervals.
  • Accountabilities include work and people scheduling, performance management and recommendations for hiring decisions.
  • Judgement is required in resolving complex problems based on experience.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers.
  • Occasional contact with external contractors/vendors.

 

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

 

Required:

  • Bachelor's degree required or equivalent combination of education and experience.
  • 06-08 years related experience required.
  • Applicable industry/professional certification required.
  • Regular and predictable attendance
  • Secrecy and invention agreement and non-compete agreement, Ability to work non-standard schedule as needed

 

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:Reaching upward and downward, Push/pull, Stand
  • Frequently:N/A
  • Constantly:Sit

Activities:

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

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, Other
  • Frequently:N/A
  • Constantly:Office environment

 

Notices

Equal Opportunity Employer Veterans/Disabled

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