Senior Development Quality Manager

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.

     

JOB DESCRIPTION:

Senior Development Quality Manager

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.

The Opportunity

This position works out of our Menlo Park, CA location in the Structural Heart division. Structural Heart Business Mission: Why We Exist! Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

We are seeking a passionate Senior Development Quality Manager to lead and develop an engineering team responsible for operations quality, design changes, transfer projects, and post-market surveillance within assigned product areas. The manager will be responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established requirements, standards and agency regulations.

What You’ll Work On

• Provide leadership in direct support of medical device manufacturing.
• Management and development of Quality Engineers and Technicians.
• Own the activities of the Post-Production Quality Engineering team.
• Provide Quality leadership over new product development efforts governed by Design Controls processes and procedures
• Ensure successful planning, management and execution of area projects.
• Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
• Passionately find opportunities to assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Purposefully identify and lead activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Define and implement Process Control & Monitoring systems for KPIV and KPOV throughout the product lines – Critical Parameter Management.
• Provide influential peer leadership with international partner site to drive quality improvements.
• Approve/author experimental plans, protocols and reports, including supporting teams on appropriate statistical analysis techniques.
• Identify Quality Initiatives and lead multi-functional teams to complete them.
• Provide enthusiastic, diligent, and fact-based communication to Sr. Management team, peers and team.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Lead the Nonconformance and Real-time data management portions of the quality System.
• Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and improvements.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.

Required Qualifications

• 4 year degree; industry certification or advanced degree, electrical or mechanical engineering pr