Sr Director, Quality Assurance Franchise (Med Dev)
B. Braun Medical, Inc.

US-PA-Allentown | US-CA-Irvine
US-FL-Daytona Beach

Job ID: 2023-22297
Type: Regular Full-Time
# of Openings: 1
Category: Quality
Corp at Allentown Auxiliary

Position Summary:
Responsibilities: Essential Duties
  • Responsible for Lead a team of direct and indirect quality functions with accountability for the 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 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 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 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.

Apply Here:

See attached document for additional position details.

File Attachments