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.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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.

The salary for this role is between $156,400 and $312,800.

The Opportunity

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That’s why we’re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

Our location in Alameda, CA currently has an opportunity for a Quality Director, Complaint Investigation. This individual will develop, establish and maintain operational quality assurance programs, policies, processes, procedures and controls ensuring that the organization conforms to established standards and agency regulations. This position ensures quality standards of existing products and services, as well as developing programs to focus employees on quality improvement.

What You’ll Work On

• Develop and participate in setting quality assurance strategies and regulations.
• Assesses and advises on potential risks, ensures compliance and gives recommendations.
• Takes responsibility for all quality control aspects of the process (laboratories studies, clinical research, testing, operations, raw materials, production, finished product or services).
• In charge of audits and regulatory inspections.
• Manages relationships with external vendors, contractors or suppliers to ensure that their products or services meet the organization's quality standards.
• Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers.
• Establishes standards for the disposition of finished product by devising evaluation tests, methods, and procedures.
• Establishes rework standards by devising inspection and physical testing methods and procedures.
• Define and communicate overall vision and cascaded objectives for the departments.
• Provides overall leadership for Quality policies, approaches, and standard practices. Maintains alignment with US and International regulations and standards, as well as Abbott quality systems.
• Provide overall functional Quality leadership which may include: Supplier Quality Assurance, Operations Quality, Receiving Inspection
• Some functional site responsibilities may require providing high level direction of all activities related to incoming inspection of supplied product in accordance to policy, including first article inspection, non-conforming material review, acceptance testing, segregation of material and MRP transactions.
• Some functional site responsibilities may require providing high level direction of all activities related to calibration of measurement equipment used throughout the organization in accordance to policy, including equipment traceability, out of tolerance management, and interval management.
• Assures Quality provides technical support and services to Operations and Research & Development functions. Supporting approved projects and objectives of both functions.
• Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Be a champion of Quality, Lean and disciplined problem solving throughout the organization to identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Provide influential leadership with US and OUS sites to drive proactive quality improvements and harmonization.
• Provide diligent and fact-based communication to Executive Management team, peers, and team.
• Provide management and development of the Quality staff.
• Be an effective member of the cross-functional Director organization to foster continuous quality compliance, cost, and predictive measures improvements by maintaining effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Support all Divisional initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor’s Degree in a related field or an equivalent combination of education and work experience
• Minimum 10 years in Quality desired with at least 3+ years management of demonstrated compliance excellence, value improvement, risk reduction, and cost containment

Preferred Qualifications

• Class III or II medical device background.
• Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies.
• Strong leadership skills with demonstrated ability to create momentum and deliver excellent results.
• Strong organization, speaking skills, and influential management ability.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Ability to travel approximately 25%, including internationally.

Apply Now

• 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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The salary for this role is between $156,400 – $312,800