Back to jobsOversee the necessary monitoring systems are implemented, and signals responded to for the CAPA process, post-market surveillance, document and records controls, across the Neuromodulation franchises.
Ensure that the necessary monitoring systems are implemented, maintained and trend signals are appropriately responded to for product performance measures, document and records controls, material and supplier controls, post market feedback, non-conformances and CAPAs. Escalate as necessary all non-conformance events and product design and/or performance issues that require formal review and consideration of field actions.
Serve as point of contact in coordinating data analysis, KPIs, production and process controls as necessary for management reviews, issues escalation, CAPA review board, and complaint review board.
Lead inspection and audit readiness preparation and audit/inspection response activities.
Understand emerging external and internal quality system changes and impact to the Neuromodulation division. Ensure quality system updates are appropriately implemented.
Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements)
Create and develop a strong quality systems team that fosters CAPA, risk management, management review, quality system training and talent development across the function.
Collaborate with corporate quality systems SMEs to improve division quality system compliance performance
Maintain weekly and monthly quality system status reports as necessary for VP updates to division leadership team.
Foster opportunities for the application of AI and other tools to drive overall improvement and sustained quality system compliance across the division.
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, mentoring and coaching individual and team performance while visibly demonstrating the core values of BSC in everyday leadership style.
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)
