Global Director, Supplier Quality & Strategy

Abbott; Pleasanton (CA); On-site; USD 172,000 - 344,000; Full time

Job summary

Abbott is seeking a Director Supplier Quality to lead global supplier quality strategy for diagnostics, medical devices, and related services. You will build partnerships with internal and external stakeholders, establish supplier quality systems, and ensure regulatory compliance across global sites.

You will recruit and coach talent, drive quality improvements, manage supplier audits and third-party manufacturers, and influence strategic decisions at senior levels to meet customer requirements.

Qualifications

• Experience in regulated environments to meet the skills and responsibilities of the position.
• Knowledge of FDA and ISO Quality System Requirements and other applicable US CFR for Devices.

Responsibilities

• Champions quality and compliance through awareness of requirements, trends and other external influencing factors especially in the area of supplier management.
• Builds strategic partnerships with internal and external stakeholders to further departmental and organizational objectives.
• Establishes a progressive supplier quality vision and strategy by recognizing situations and anticipating at a broad industry level and influences strategic decision making beyond own functional area.
• Develops operational strategy that comprehends and anticipates external compliance and regulatory requirements.
• Develops supplier quality strategy and planning that enables top-line growth and margin improvement.
• Establish Supplier Quality Systems that follow global regulatory requirements and meet business needs.
• Recruits, coaches and develops talent.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Management of supplier audits, divisional budget, qualification, incident resolution, metric reporting and validation for division products and parts (e.g. meters, sensor assemblies and accessories).
• Third Party management of domestic and international sites for finished device manufacturing including yield and quality data reports, finished device acceptance, validation, external inspections, incoming, equipment calibration and maintenance activities.
• Management of third party service providers for offsite inspections and miscellaneous quality activities.
• Managing and acceptance of Third Party Manufacture of products (e.g. meters, readers, sensor devices and accessories).
• Analyzes data, makes decisions or provides recommendations to senior staff regarding supplier quality related crises.
• May be accountable for guiding cross functional resources to ensure program deliverables are effectively executed and that design control and quality system requirements are met.
• May support efficient decision making by Sr. Management by providing scenario analysis, risk identification and contingency plans.
• May implements project planning tools to support product development programs and ensures site wide communication of program status to drive engagement of staff.

Education

Bachelor’s degree + 16 years experience

Minimum 10 years’ experience in regulated environments

Substantial knowledge of FDA and ISO Quality System Requirements

Job description

Abbott is seeking a Director Supplier Quality to lead global supplier quality strategy for diagnostics, medical devices, and related services. You will build partnerships with internal and external stakeholders, establish supplier quality systems, and ensure regulatory compliance across global sites.

You will recruit and coach talent, drive quality improvements, manage supplier audits and third-party manufacturers, and influence strategic decisions at senior levels to meet customer requirements.