Global Supplier Quality Director

This newly organized role is responsible for managing the recently integrated global supplier quality team that is responsible for overall supplier quality working closely with cross-functional partners (procurement, engineering, supply chain, and service).

The Supplier Quality Director will also drive our global “quality at the source” initiative which focuses on proactive measures to prevent defects rather than detection downstream. This will require leading the team to enhance upfront collaboration with suppliers to establish more robust processes at the supplier and a higher quality output utilizing PPAP, SPC, Six Sigma, and Lean methodologies. In addition, collaboration with incoming inspection, product quality, procurement, and engineering teams globally will be key to the overall success of this program.

• Establish requirements for suppliers to meet process and quality standards for GMPs.
• Facilitates the development of collaborative relationships with suppliers, ensuring long-term partnerships for the consistent delivery of high-quality components and materials.
• Develop systems and procedures for selecting and monitoring vendors and suppliers to ensure their ability to meet engineering and quality standards with quality at the source.

The supplier quality organization includes both the strategic and operational components of supplier quality with 3 regional teams globally. Global team reporting is both in a direct reporting and matrix reporting structure. The role is responsible for the following supplier quality activities including:

• Supplier Selection & Early Involvement
• Supplier Qualification
• Supplier Monitoring and Development
• Quality at the Source / PPAP / APQP
• Quality Compliance
• NPI work with suppliers,
• Product Acceptance
• Quality Controls
• Continuous Improvement

Responsibilities also include supplier quality process ownership, project management of supplier quality issues, oversight of all supplier development plans as well as oversight (tracking and communications) of supplier quality escalations.

Minimum Required Skills and Knowledge:

• Strong influencing skills, building and maintaining successful and effective trust-based working relationships with direct reports, management peers, and other colleagues.
• Proven experience in project and change management, process excellence, business management techniques and organizational development.
• Deep experience leading global supplier quality organizations in a regulated industry.
• Knowledge of supplier quality requirements for a medical device company and best practices that should be followed globally.
• Specialized experience with creating and executing communication plans both for technical and non-technical stakeholders that identify key requirements, optimum means of communication and calls to action.
• Knowledge of supplier management requirements and controls including PPAP, SPC, Six Sigma, and Lean Methodologies
• Ability to independently and proactively identify areas for improvement, drive benchmarking initiatives by measuring and comparing the performance, efficiency, or quality of a product, service, or process against the industry best practices and initiate change to improve efficiency, quality and decrease the non-conformance costs.
• Deep technical experience in supply chain and manufacturing operations (including non-conformance cost reduction initiatives, etc.) in a medical device, automotive, or related industry with deep compliance requirements
• Demonstrated track record of a self-starter mindset, operating independently on multiple priorities with minimal oversight.

Education and Experience:

• Bachelor’s degree and 10+ years of related experience or Master’s degree with 6+ years of related experience in both strategic and tactical roles.
• Strong business acumen with, at minimum, a working knowledge and understanding of Supplier Quality, Procurement, Engineering, Manufacturing, Finance, Quality, Regulatory
• Experience to hire, retain, inspire, coach and scale diverse, geographically dispersed, high-performing teams.
• Proven experience and track record of establishing specific, measurable, achievable, relevant, and time-bound team goals, objectives, and expectations with clear direction and delegation to meet the project goals and objectives.
• Capability to deliver large scale cross-functional process improvement projects at a global (multi-site) level. Competency in developing, organizing, and prioritizing key executive leadership and committee activities to facilitate strategic decision making and achieving support through the presentation of data-based quality models and ROI gains.
• Technical proficiency with Enterprise Resource Planning (ERP) systems, preferably SAP HANA, SAP Manufacturing Execution System (MES) and SAP Manufacturing Integration
• Possession of excellent data analysis and visualization skills using Microsoft Excel, Microsoft PowerBI, Tableau, QlikView or similar.
• Knowledge of ISO, MDSAP, QSR and cGMP regulations and standards.
• Knowledge of Performance Improvement, Six Sigma and Lean methodologies.