QA Quality Specialist II - Sys

Company: B Braun US Device Manufacturing LLC
Location: Allentown
Posted on: April 17, 2025

Job Description:

B. Braun Medical, Inc.


Company: B. Braun US Device Manufacturing LLC
Job Posting Location: Allentown, Pennsylvania, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 4248

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
Position Summary:

• 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 ensure regulatory compliance.
• The role will serve as a Quality Systems SME in CAPA, Audits, and Change Control (including Level 2) while serving as backup support in Training & Document Control.
• The role is crucial for sustaining our Quality System in areas requiring improvement to continue to meet regulatory requirements and expectations. 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. 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 full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
    • Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of other peers.
    • Judgement is required in resolving complex problems based on experience.
    • Contacts are primarily with direct supervisor, peers and subordinates.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 preferred.
      • Regular and predictable attendance 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. 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
          • Frequently:Stand, Sit
          • Constantly:N/AActivities:
            • Occasionally:Finger feeling, Push/pull, Reaching upward and downward
            • Frequently:Seeing - depth perception, color vision, field of vision/peripheral, Sitting
            • Constantly:Hearing - ordinary, fine distinction, loud (hearing protection required), Talking - ordinary, loud/quickEnvironmental Conditions:
              • Occasionally:N/A
              • Frequently:N/A
              • Constantly:N/AWork 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:Lab environment
                • Frequently:N/A
                • Constantly:Office environmentTarget Based Range: $81,392-$101,740
                  #LI
                  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.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.We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.
                  
                  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.
                  
                  
                  
                  PI40dfcfc7ac31-37248-37420005

Keywords: B Braun US Device Manufacturing LLC, Bethlehem , QA Quality Specialist II - Sys, Other , Allentown, Pennsylvania