Quality System Manager

The Quality System Manager is responsible for managing the QMS including establishing, implementing, and maintaining the strategy, policies, and processes for the global and site-specific Quality System within the Invitro Diagnostics (IVD) group within the TE Medical Business Unit, while ensuring compliance with the relevant regulations and standards. The Manager of Quality Systems and team will develop and lead cross-site Quality System improvement activities and drive best practice adoption.  This role will provide leadership in Quality System areas such as risk management, change control, CAPA, internal/external audits, training, and non-conformance handling across the organization. This role reports to the Global Head of Quality. This is a US remote role.

    
Job Responsibilities
    Develops, establishes, and maintains a Global Quality Management System across sites of varying maturity and compliance risks.
    Ensures Global Quality Systems processes, and practices meet customer and regulatory requirements.
    Leads a cross functional team of employees in the achievement of organizational goals.
    Subject Matter Expert and system owner for Global Quality Systems processes 
    Drives harmonization of Global Quality Management System processes within the QMS system (CAPA, NC, Audit, Training, Change Management and Documentation Control)
    Guides, coaches, and trains direct reports on Quality Systems compliance and drives best practices throughout the organization.
    Excellent aptitude to manage change with the ability to overcome resistance and persist in achieving goals.
    Applies in depth knowledge of the Quality System requirements and leads the deployment of the eQMS system for new sites and businesses as acquired.
    Leads site quality teams to implement changes to the Global Quality Management System as driven by internal and external factors in compliance with policies and best practices.
    Acts as an effective leader managing a team of Quality Systems professionals, resolving issues, and tracking project resourcing.
    Benchmarks and networks within TE and outside the company to develop new ideas, and drive these to execution. Drives cross-site best practice sharing.
    Drives awareness of current regulatory audit 'hot-topics' by keeping current on external reports and information; shares this information globally. 
    Ensures all sites are "audit ready". 
    Takes the lead during internal and external audits, as required.
    Provides guidance to the business on QSR/ISO requirements.
    Fosters an environment of team collaboration
 

    Bachelor's Degree with a scientific or engineering emphasis.
    8+ years' related experience; regulated medical device environment, preferred
    2+ years' experience managing / supervising engineers and technicians 
    Strong networking skills and organizational awareness must be able to work effectively with individuals at all levels and across multiple locations within the global organization. 
    Excellent interpersonal skills - must be able to understand the opinions and perspectives of internal and external stakeholders and influence others without authority.
    Ability to facilitate the development of direct reports
    Lead Auditor ISO 13485 certification is a plus
    Knowledge of the eQMS Smartsolve system is a plus
    In-depth knowledge and experience with FDA/GMP/QSR and ISO 13485
    Highly organized with strong ability to prioritize tasks and work on own initiative
    Willingness to travel domestically and internationally as needed (~20% of time)
    Ability to work flex work hours as needed to support global sites across time-zones