Senior Development Quality Engineer

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 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. Main Purpose of the Role The Senior Development Quality Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Main Responsibilities Lead on-time completion of Design Control Deliverables • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities • Lead Risk Management activities from product Concept through Commercialization • Lead design test and inspection method development, and lead method validation activities • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps • Support manufacturing process development & qualification for new product commercialization and product changes • Support/lead and ensure internal & external audit responses • Support/lead and ensure on time product re-certifications • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications • Accountable for development, execution and analysis of biocompatibility and sterilization qualifications • Complete Document Change Request Reviews in a timely and objective manner • Develop and lead other team members. • Perform other duties and responsibilities as assigned by management. • Support/lead all Company 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. • Complies with U.S. Food and Drug Administration (FDA) regula