Director, Quality Assurance (Active Device)

Company: System One
Location: Carrollton
Posted on: March 18, 2023

Job Description:

Our client; a medical and pharmaceutical device company is looking add a Director of Quality Assurance to their Active Medical Device team in Carrollton, Texas.


Title: Director, Quality Assurance (Active Medical Device)

Location: Carrollton, Texas

Schedule: Mon-Fri

Type: Direct

Start date: Immediate.

Responsibilities:

• 
  
• 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, to adapt product quality strategy accordingly.
  
  Requirements:
  
  • 
    
  • 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.
    

Keywords: System One, Carrollton , Director, Quality Assurance (Active Device), Executive , Carrollton, Texas