Quality Specialist

Company: Abbott Laboratories
Location: Santa Clara
Posted on: January 11, 2021

Job Description:

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 107,000 colleagues serve people in more than 160 countriesABOUT ABBOTT DIAGNOSTICS: The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbottu2019s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health. Our pioneering technology spans the world of healthcare operations u2014 with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.u00A0 Investigates complex complaints in a compliant manner to determine if product is performing within specifications by completing a variety of tasks such as reviewing product documentation, tracking and trending data, submitted data, and/or consulting with third parties and performing product testing. Maintains compliant and detailed complaint records.Our location in Santa Clara, California currently has an opportunity for a Quality Specialist.WHAT YOUu2019LL DOAbility to work in a dynamic & fast paced environment. Ability to work on numerous projects in parallel. Must be a strong communicator with peers, team members, and management. Anticipates the impact and risk of decisions and actions at both the project and organizational level.u00A0 Comprehends the implications & consequences of how proposed changes and project demands will affect both internal & external customers.Primary function is to review and participate in all aspects of product design control for On-Market and In-Development activity.u00A0 It is expected to have a firm understanding of the design input, risk management, design verification, design validation and design output/transfer processes & tools as applied to software product development.u00A0 Effective navigation & facilitation of these processes and procedures is paramount to ensuring product teams deliver safe and effective products.* Responsible for implementing and maintaining the effectiveness of the quality system.* Design/Change Control - Software responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.* Risk Management u2013 Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEAu2019s, etc.* Design Verification/Validation u2013 Understands and applies basic Design Verification/Validation methods & principles.u00A0 Participates in the development, modification and design review of Protocols, Data Summaries & Records.* Complaint/Defect Evaluation - Investigates complex complaints and/or defects with management oversight. Provides compliant solutions to a variety of complex problems. Ensures compliant documentation related to area of responsibility.* Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.* Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.* Quality Engineering u2013 Participates on project teams and technical review boards.u00A0 Coordinates quality decisions between different quality and engineering groups.u00A0 Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.EDUCATION AND EXPERIENCE, YOUu2019LL BRINGRequired * Bacheloru2019s Degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.u00A0u00A0* At least 3 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.* Demonstrates understanding of how their function supports the business. Demonstrates technical and business competencies that drive results and continuous improvement.Preferred * B.S. in Computer Science; Software Engineering; Biomedical Engineering; Life Science or closely related discipline is required or relevant combination of education & experience.u00A0 MS is preferred.u00A0 3+ years experience covering the entire design control process in a team-oriented environment.* Prefer tool experience with HP Quality Center, Serena Business Manager, Siemens Teamcenter Product Data Management & IBM DOORS.u00A0 Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11.u00A0 Project experience in software testing practices, methodologies and techniques, particularly in testing medical devices is a plus.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 communitiesLearn more about our benefits that add real value to your life to help you live fully:u00A0 www.abbottbenefits.comFollow 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

Keywords: Abbott Laboratories, Santa Clara , Quality Specialist, Other , Santa Clara, California