Quality Engineer

Quality EngineerAbbott 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 AbbottAt 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 of which you dream.An excellent retirement savings plan with high employer contributionTuition 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 OpportunityThis position works out of our Houston, TX location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.THIS IS AN ONSITE DAILY REQUIRED POSITION.What You'll Work OnThis position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within manufacturing and during product manufacturing site transfer activities.MAIN RESPONSIBILITIES• Identify and implement effective process control systems to support the qualification and on-going manufacturing of products in compliance with FDA 21 CFR Part 820/ISO 13485 requirements• Lead implementation of quality assurance processes, process controls, and CAPA systems in alignment with regulatory and internal requirements• Assist in the development and execution of business systems that effectively identify, escalate, and resolve quality issues within a regulated framework• Apply structured problem-solving methodologies (e.g., DMAIC, root cause analysis) to investigate and resolve quality issues• Design and conduct experiments to support process validation, optimization, and continuous improvement• Develop and approve validation documentation including protocols and reports (IQ/OQ/PQ, TMV where applicable)• Lead process control and monitoring of Critical-to-Quality (CTQ) attributes and specifications• Lead and implement continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies• Lead nonconformance investigations, including NCR, CAPA, and complaint-related analysis, ensuring timely closure and effectiveness verification• Participate as a core team member representing Quality in cross-functional product transfer and sustaining teams• Lead and maintain risk management activities in accordance with ISO 14971, including hazard analysis, risk assessment, and risk control verification• Work with Microbiology and Manufacturing to ensure compliance with environmental monitoring, contamination control, and sterilization requirements where applicableRequired Travel: 10-15%. For the first 6-12 months travel could be up to 50% including travel outside of the United States.Required EducationBachelors Degree Engineering or Technical Field.Required Experience2+ years Engineering experience and demonstrated use of Quality tools/methodologies.Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971Solid communication and interpersonal skills. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.Advanced computer skills, including statistical/data analysis and report writing skills.Prior medical device experience preferred. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).ASQ CQE or other certifications preferred.Experience working in a broader enterprise/cross-division business unit model preferred.Ability to work in a highly matrixed and geographically diverse business environment.Ability to work within a team and as an individual contributor in a fast-paced, changing environment.Ability to leverage and/or engage others to accomplish projects.Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Multitasks, prioritizes and meets deadlines in timely manner.Strong organizational and follow-up skills, as well as attention to detail.The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.