Quality Systems Director

Recruiter: Spencer Gregory Hale

Quality Systems Director— Alpharetta / Johns Creek

About the role:

The Quality Director leads a team of Managers, Senior Engineers, Engineers, Technicians and other professionals to ensure full compliance to all GMP/QSR practices and standards as defined by the FDA, ISO and other regulatory bodies.  The Quality Director is an integral part of the Site Leadership Team and works closely with the Operations Site Leader, as well as collaborating closely with leaders from the Endoscopy and Peripheral Interventions Divisions.

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.

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Interfaces with the Global Supply Chain, Research & Development, and Regulatory Affairs functions to accomplish quality objectives. Establishes quality systems and plans to assure design and manufacture of the highest quality products. Interacts with outside regulatory agencies as a Boston Scientific representative.

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

 Requisition ID: 594665

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.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.