The Sr, Director of North America Operations Quality is the primary Quality leader of the NA Operations Quality team. This is a senior leadership role that includes overall quality strategy development and execution as well as day-to-day oversight of product quality across the NA sites. This role ensures that both quality plan objectives and general oversight of quality within manufacturing achieve or exceed the organization’s performance standards.
Key areas of focus will be: Execution and delivery of site quality plan commitments aligned with Jabil Healthcare’s Quality strategy, process and quality improvement programs, including focus on culture, talent development, organizational capability needs, and functional efficiency. This role also supports continued compliance with all elements of the Quality Management System at the NA sites, ensuring processes are established and maintained in accordance with policies, procedures, and global regulatory requirements. This role helps communicate the vision and strategy around company and customer expectations and ensures Quality System performance is measured and routinely tracked, trended, and reported to Executive Management.
This position requires strong collaboration across the manufacturing sites, partnering with Operations leaders, Jabil business leaders, Manufacturing, Supply Chain, Sourcing, Manufacturing Engineering, and Distribution to provide clear strategic alignment to ensure business needs are met. The Sr, Director of NA Operations Quality participates with other senior leaders to embed a strong culture of quality with business strategic plans and objectives. This role engages in decisions on operational matters that may impact quality and ensures effective resolution through effective planning, data analysis, trending, and coordination with peers supporting the various cross-functions.
This role helps drive Quality as a competitive advantage and works with customers to drive efficiencies within Product Lifecycle Management, understanding business needs (i.e., current and future) to help determine the framework of the organization that is both efficient and adaptable to business and customer needs.
- Establishes and maintains processes and controls ensuring that the performance and quality of product conforms to established customer, company, and regulatory requirements for the North American manufacturing facilities. Areas of responsibility include Quality Engineering, Calibration, Document Control, Inspection & Test, Product Release, CAPA, Nonconforming Material, Design Transfer, and Supplier Controls.
- Participate in global quality initiatives and facilitate the sharing of best practices
- Ensures the manufacturing facilities address customer feedback and complaints in an appropriate and timely manner
- Executes responses to field actions and coordinates regional/global responses with senior leadership, as appropriate
- Define efficient quality processes and tools that support the company’s business strategies
- Coordinate with global Quality and Operations groups on global Quality Systems strategies that support site and regional goals and objectives
- Ensures manufacturing facilities have appropriate resources with necessary competencies to effectively execute the Quality System. Oversees the Quality Management Representatives at each of the North American manufacturing facilities.
- Establishes and monitors key performance indicators for the measurement of the Quality System and costs associated with Quality in each manufacturing facility
- Develops and drives Quality cost savings in each manufacturing facility to deliver on savings commitments while maintaining compliance to both customer and regulatory requirements
- Collaborates with regional and global Quality and Operations leaders to educate on Quality requirements, share best practices, and deploy global solutions for operational improvements
- Ensures audits conducted by global health authorities, customers, and other third parties are properly hosted and supported team members to yield minimal audit observations and business disruption
- Partners with Regulatory Compliance leadership to ensure facilities assessments are effective via internal audits and management reviews. Drives and implements corrective and preventive actions, as appropriate.
- Champions a customer-centric culture sustained by implementation of both regional and site-specific programs. Works with the global organization to align culture and values across Jabil Healthcare.
- Develops and disseminates strategy for talent attraction, development, and retention to enhance the Quality Operations talent pipeline to help create future leaders within Jabil Healthcare
- Partners with Business Development leadership to present Quality System performance to existing and potential customers
- Comply and follow all procedures within the company security policy
- Understand the business, consider current trends in the medical device industry, and have the vision to develop processes that are efficient and adaptable
- Perform other duties and responsibilities as assigned
Education & Experience
- Degree in Management or Engineering required, and master’s degree in technical field or Business Administration preferred
- Minimum of 10 years work-related experience in Quality Management within medical devices / in vitro diagnostics
- Operations management experience preferred
- Strong business acumen as well as interpersonal and performance management skills for teams with diverse cultures and business practices
- Strong written/oral communication, influencing, and leadership skills. Able to communicate at all levels of the organization.
- Knowledge and experience with Six Sigma as a disciplined, data-driven approach to continuous improvement
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