Manager Quality Assurance

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 114,000 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 Opportunity

This position works out of our Alameda, CA location in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health 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.

Reporting to the Quality Director this role will lead the No Product Return (NPR)team for ADC. The role will provide operational and strategic leadership including quality oversight of third party service provider. The role is responsible for supporting development, training, implementation, and monitoring of quality system related to Complaints Handling and specifically NPR, product quality and post market surveillance.

This person manages and develops staff including third party service provider and is accountable for their performance while providing direction to ensure metrics are generated and necessary work performed in a timely manner maintaining regulatory compliance and optimizing productivity. Establishes operating policies and procedures that affect department and subordinate sections including third party service providers. Interprets company wide policies and procedures. Develops budgets, schedules and performance standards. Work is reviewed in terms of meeting the organization's objectives and timelines.

The ideal candidate will be a division Subject Matter Expert (SME) for No product Return investigation process As process owner the role will be a Continuous Improvement Champion, helping to promote and foster a culture of transformational change and continuous improvement. Develop long term strategies to meet division goals.

This person will interact with management to reach agreement regarding significant program strategies. Present strategies and updates to management and stakeholders. Recognize the broader implications of actions and proposals on the final project outcome, related systems and activities, and general business strategy.

This person will also interface with other Manufacturing and TPS sites, internal and internal partner as required. Establishes relationships with business partners to develop strategies that incorporate value with focus on increase productivity and improve compliance

Lastly, the ideal candidate anticipates, recognizes, communicates and manages quality issues within the organization and works with appropriate cross-functional areas to recommend actions to resolve issues. They will also Implement quality standards, ensure and execute compliance on every stage of the process.

What you’ll work on

• Develop and implements Quality Assurance strategies and regulations.
• Assesses 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).
• Facilitates audits and regulatory inspections.
• Liaises with external vendors, contractors or suppliers to ensure that their products or services meet the organization's quality standards.
• Coordinates quality trainings. Responsible for ensuring that functional areas of responsibility have adequate training programs for adhering to all safety requirements and business EHS goals.
• Establish and implement necessary communication strategy for the improvement and awareness of the quality issues.
• Establish relationships with business partners to develop strategies that incorporate value, risks, operational impacts (ROI)
• and cost of proposed solutions with focus on economic profitability and customer service.
• Liaise with key service suppliers, develop resource models, forecasts, evaluates staffing needs and established service KPIs
• Determines staffing and other resource requirements needed to achieve business goals and compliance requirements.

Required Qualifications

• Minimum 7-10 years of experience in function or related field. 4-6 years of direct supervisor experience or equivalent
• Degreed required (Associate, Bachelor, Masters) with adequate years of working experience.

What We Offer

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 base pay for this position is $109,300.00 – $218,500.00. In specific locations, the pay range may vary from the range posted.