Director- Site Quality Head

Abbott Laboratories • Austin, TX

133d • $147,300 - $294,700

About The Position

Abbott Diabetes Care has an opportunity for a Director - Site Quality Head. The Director leads strategy, management and support for global supplier quality associated with the division. Areas include suppliers (parts and services), Third Party Manufacturers (TPM), and Original Equipment Manufacturers (OEM), service providers and consultants. Establishes quality systems and plans for supplier controls to assure design, development and manufacture of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies.

Requirements

• Bachelors Degree or an equivalent combination of education and work experience.
• Minimum 10 years in regulated environment to develop competence to meet the skills and responsibilities of the position.
• Substantial knowledge of FDA and ISO Quality System Requirements and other applicable US Code of Federal Regulations 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.
• 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.
• 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 implement project planning tools to support product development programs and ensures site wide communication of program status to drive engagement of staff.
• Quality Management System (QMS) responsibility for TPM ensuring robust compliance and alignment with FDA, ISO, cGMP, etc.
• Lead continuous improvement initiatives within the QMS framework.
• Manage TMP relationship with respect to Quality Support audits, respond to quality concerns, and provide data transparency.
• Ensure product release criteria meet specifications and customers' expectations.
• Coordinate CAPA (Corrective and Preventive Actions) processes for ADC.
• Maintain audit readiness at all times.
• Support and lead divisional initiatives as required.
• Influence the TPM organization to strive for excellence in everything they do.

Benefits

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan.
• Free coverage applies in the next calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree