Director, Quality Assurance Franchise (Active Medical Device)

Company: B. Braun Medical
Location: Allentown
Posted on: June 23, 2022

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 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 . Responsibilities

Position Summary: Responsibilities: Essential Duties

• Responsible for Lead a team of direct and indirect quality functions with accountability for the Active Medical Device Franchises Quality Assurance and Compliance programs goals. Accountable to ensure all products are designed and produced to meet specifications, regulatory body, and BBMI standards.
• Support Business unit management to meet their division objectives through the franchise quality goals.
• Represents the Corporate Quality voice in any Franchise leadership strategy meetings, manufacturing plant reviews, multi-functional meetings related to Active Medical Devices, and design projects.
• In alignment with the Corporate Compliance team, manage the franchises compliance program required portions of cGMP (QSR) 210/2011/820, Medical Device Regulation (MDR), Canadian Medical Device Directive, CFDA, PMDA and other agencies.
• In alignment with the Corporate Quality Systems team, manage and drive QMS compliance remediation as necessary.
• Oversee the franchise QA metrics (KPIs) to track Quality initiatives and effect overall improvements QMS activity.
• Responsible for keeping the Corporate Quality and Business management teams informed of quality status of products, manufacturing sites, and key projects.
• Coordinate FDA required post-market surveillance programs with Corporate Post Marketing Surveillance Department.
• Lead and manage investigations for product field actions and/or recalls, as applicable.
• Facilitate driving a Quality culture and the Corporate strategy for a single QMS into the Active Medical Device Operations team.
• Develop and maintain the Medical Device franchise quality department budget, including manufacturing site resourcing for daily operations and special projects.
• Lead and/or participate in multi-departmental and multi-site teams to implement quality strategies.
• Represent BBMI with Regulatory Authorities related to product and quality issues in the Active Medical Device franchise.
• Review and approve document changes for Quality Assurance Departments as required,
• Ensure an understanding of the external regulatory requirements with key franchise and business personnel, in order to adapt product quality strategy accordingly. The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. General: Expertise: Knowledge & Skills
  • Requires breadth of professional field and industry knowledge.
  • Ability to integrate critical information and champion advanced strategies/concepts through the organization.
  • Drives development of advanced technologies, principles and processes.
  • Directs the activities of a broad functional area through division heads who are responsible for planning, budgeting, costs, methods and employees.
  • Determines actual organizational structure and allocation of resources.
  • 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, Master's degree preferred.
    • 10-15 years related experience, plus a minimum of 5 years management experience required.
    • Regular and predictable attendance
    • Occasional business travel required, Valid driver's license and passport 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. Additional Information
      
      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:Sit
        • Constantly:N/A Activities:
          • Occasionally:Climbing stairs/ladders, Push/pull, Reaching upward and downward, Standing, Walking
          • Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quick
          • 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, Other
              • Frequently:N/A
              • Constantly:Office environment What We Offer 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
                
                Through its Sharing Expertise® initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. Notices
                
                Equal Opportunity Employer Veterans/Disabled 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.
                
                
                
                PI181231989

Keywords: B. Braun Medical, Allentown , Director, Quality Assurance Franchise (Active Medical Device), Healthcare , Allentown, Pennsylvania