Director Supplier Quality

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 a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

WORKING AT ABBOTT

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to :

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Job Title

Director Supplier Quality

The Opportunity

The Director Supplier Quality 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.

What You’ll Work On

• 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.

Required Qualifications

• Bachelor’s degree + 16 years experience
• Minimum 10 years’ experience in regulated environments 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

Preferred Qualifications

• Master’s degree preferred

Abbott is an Equal Opportunity Employer, committed to employee diversity.

The base pay for this position is $172,000.00 – $344,000.00. In specific locations, the pay range may vary from the range posted.