Sr Quality Systems Excellence Specialist

Company: B. Braun Medical Inc.
Location: Allentown
Posted on: November 23, 2021

Job Description:

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 .
Responsibilities
Position Summary:

Responsible for establishing and maintaining B. Braun Medical Inc (BBMI) Corporate Operating Procedures for various Quality System Elements in accordance with national and international guidelines, standards and regulations. The desired candidate will have a good understanding and extensive experience with FDA and International Regulatory compliance expectations related to process validation (IQ, OQ, PQ and PPQ), cleaning validation and their associated execution. A background in statistics including sampling plans, confidence and reliability statements and other related statistical tools is desired. The ideal candidate will also have experience with establishing and maintaining Quality System processes that work in unison with or outside of process validation. The ability to work in a cross functional team and ensure compliant execution is a must.


Responsibilities: Essential Duties

• 
  
• 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.
  
• Senior level position additionally:
  
  • 
    
  • Partners with Quality Operations at all BBMI sites on quality objectives related to quality systems and Serves as the Quality project leader and centralized team member for these initiatives.
    
  • Ensures user requirements are properly defined and documented, systems are structured to meet established requirements and training is effectively executed to all affected personnel prior to
    
  • Utilizes lean and six sigma approaches to quality system processes to ensure processes are not only compliant but also efficient and
    
  • Leads Kaizen events with diverse team members to achieve desired results within established timeframes.
    
  • Implements and maintains the Corporate Operating Procedures and centralized processes and templates, identifies and implements process improvement tools for Quality Systems to ensure the process requirements of Quality Compliance systems are integrated throughout the organization.
    
    
    
    
    
    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.
      
    • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.
      
    • 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, Master's degree preferred.
        
      • 10-12 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.
        
        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.

Keywords: B. Braun Medical Inc., Allentown , Sr Quality Systems Excellence Specialist, Other , Allentown, Pennsylvania