Senior Specialist 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. JOB DESCRIPTION: Sr. Specialist Quality Assurance Engineer - Williamson 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. Youll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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. The Opportunity The Sr. Specialist Quality Assurance Engineer will onduct quality-related activities to deliver consistent; high quality documents; services; products and processes. This is a 5 days/week onsite opportunity based out of Alameda, CA. What Youll Work On Defines project goals and milestones. Responsible for timely project completion. Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. May lead projects with cross-functional or broader scope. Interacts effectively with employees, manager, and cross-functional peers. May represent own team while on cross-functional project teams with other functional leaders. Provides guidance and trains other Professionals and Technicians. May provide oversight to one or more QA professionals and/or contractors. Communicates confidently and effectively with management, peers, and key stakeholders. Implements tactical solutions related to assignment. Able to contribute functional skills and expertise broadly. Directly influences project direction and scope. Scope includes one or more QA functions, with general knowledge of other related disciplines. Quality System Compliance Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate. Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues. Risk Management Ensures evaluation of product safety and efficacy and elevation of risk-based issues. Creates and reviews risk management documentation to reduce or eliminate risk. Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system. Provides solutions to a wide range of problems. Solutions are compliant, innovative, thorough, practical and consistent with organizational objectives. Ensures compliant documentation in area of responsibility. Quality Engineering - Applies solid understanding of quality system elements from product inception through launch. While recognizing project interdependencies and with minimal oversight, leads complex quality discussions across various departments including, as needed, external suppliers. Ensures compliant documentation; carrying out tasks related to area of responsibility with management oversight. Decisions may have short and long term impact. Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions. Represents the site as an SME or Process Community Member Identifies critical parameters associated with change Provides guidance and trains other professionals and technicians Complaint Evaluation Investigates complex complaints with little management oversight. Required Qualifications Bachelors degree in Life Sciences, Engineering, or a related discipline. Minimum of 5 years of experience in Quality or a related field. Candidates with an advanced degree (Masters or Ph.D.) may qualify with less experience. An equivalent combination of education and relevant work experience will also be considered. Preferred Qualifications Preferred experience in the Healthcare industry. Has a history of completing successful projects and driving positive compliance outcomes Apply Now 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. Divisional Information Medical Devices General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ngersticks. Diabetes Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology. The base pay for this position is $98,000.00 $196,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ADC Diabetes Care LOCATION: United States > Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter