Boston Scientific Quality Systems Director 

United States, Georgia, Alpharetta 

214084035

Spencer Gregory Hale

About the role:

This leader will initially be based at the Alpharetta GA site and will transition to the new Johns Creek GA site during 2025 as activities at Alpharetta wind down, and transfer to the new Johns Creek Facility. He/she/they will provide overall direction and quality leadership (Management Rep) for Alpharetta manufacturing & distribution activities, as well as the John Creek site commissioning and transfer, and ultimately the Alpharetta facility decommissioning and Johns Creek site operations.

Your responsibilities include:

• Provide leadership and direction to his/her/their team and ensure a Quality Management System exists to meet the various requirements of a medical device manufacturing facility.
  • Ensure that the necessary monitoring of and management of processes including storage, retention and review, establishment of internal auditing programs, verification of all products and processes to the established quality standards.
  • Validation of new products/processes or changes to existing products/processes.
• Be recognized as a team player across the organization. Build a strong and sustaining relationship with Production, Engineering, Corporate and Regulatory, external Regulatory bodies and others and be recognized as an excellent team player within the total organization on site.
• Demonstrate commitment to developing people and recognized as an expert in mentoring and coaching individual and team performance while visibly demonstrating the core values of BSC in everyday leadership style.
• Demonstrate effective change leadership capabilities.
• Ensure that the necessary monitoring systems are implemented, and signals responded to for production & process controls, document and records controls, material and supplier controls, post market feedback, and CAPA.
• Direct and control the Quality budget in collaboration with others.
• Communicate quality policies, strategies and procedures to the organization through written documents, presentations and discussions.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements)
• Continuously foster and drive a continuous improvement approach to Quality onsite ensuring that quality is the responsibility of everyone - not just the Quality department and that the Quality System is an integrated and integral aspect of the total running of the Site.
  

Minimum qualifications:

• Bachelor's degree plus 9+ years of related work experience or an equivalent combination of education and work experience
• 5+ years of experience leading a team
• Experience in managing large -scale, complex operations/programs/projects
• Experience in Quality Systems and methods
• Experience in a regulated industry such as medical device, pharmaceutical, or aerospace
• Experience within Risk Management and Quality Systems management

Preferred qualifications:

• Ability to influence and excel in collaborative leadership

• Excellent communication skills; written and oral
• Hands-on orientation with a strong work ethic
• A strong focus on customer satisfaction
• High level of integrity and dependability with a strong sense of urgency and results-orientation
• Lean business/VIP experience
• Manufacturing background

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.