Watson Health - Quality Systems EngineerInternational Business Machines Corp. (IBM Corporation) - San Jose, CA
Preferred location Cambridge, MA or Hartland, WI
As a Quality Systems Engineer
and member of the Watson Health Compliance Organization you will support the Watson Health Quality Management System (QMS). You will use your knowledge of global Pharmaceutical and Medical Device regulations and standards to maintain continuous improvement, development and post market surveillance processes for Watson Health. This will include participation in maintaining global certifications, supporting the QMS, change control, CAPAs, complaints, MDRs, recalls and non-conforming products. You will interface with the Business and Marketing functions, development teams, offering solution teams, the compliance organization, the legal department and other stakeholders to maintain compliance of the QMS.
Maintain processes for receiving, documenting, tracking, investigating, and acting on all quality records related to the QMS.
Coordinate with Design Quality Assurance engineers on development documentation and processes in relation to on-going software Offerings; including customers and business partners
Support the organization’s CAPA, complaint handling and post market surveillance processes policies and procedures in coordination and collaboration with other similar functions and, when necessary, legal counsel.
Perform ongoing post-market surveillance monitoring activities in compliance with FDA and other global medical regulations and file reports with regulatory bodies as needed.
Work with the Compliance organization and his/her immediate supervisor to ensure Watson Health has and maintains the appropriate compliance forms, information notices and materials reflecting current organization and regulatory practices and requirements.
Participate in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Oversee, direct, deliver, or ensure delivery of training and orientation to all employees, volunteers, medical and professional staff and applicable business associates related to the QMS.
Audit and monitor all regulatory-related plans throughout the organization’s network to ensure alignment between security, Q&R and privacy and security practices, manage Corrective and Preventative actions (CAPAs) and prepare reports for senior management and stakeholders.
Apply Continuous Improvement methodologies to compliance processes, tooling and workflows
Successful candidates will possess the following key attributes:
Knowledge and experience in compliance laws and regulations, access, release of information, and release control technologies including 21 CFR Part 820, MDD, ISO 13485, ISO 9001, ISO 14971, IEC 62304
Demonstrated organization, facilitation, communication, technical writing, and presentation skills.
Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity
Must have strong interpersonal communication skills as well as being a motivated team player
Good verbal and written communication skills, good team skills including project management
Maintains current knowledge of applicable federal and state healthcare regulations, laws and accreditation standards, and monitors advancements in compliance technologies to ensure organizational adaptation and compliance.
Required Technical and Professional Expertise
· BS in Life Sciences, Engineering
· At least 5 years work experience in a Healthcare medical device or Life sciences pharmaceutical company
· At least 3-5 years experience with job title/experience related to Quality Engineer, Quality Systems or Regulatory Affairs
Preferred Tech and Prof Experience
· Work experience in a SW development company preferably in Cloud and Mobile platform industry segment
· Experience working on eHealth or software-as-a-device (SaMD), software-driven medical devices
· Professional certifications: CQE, RAPS, etc.
IBM is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. IBM is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
16 days 16 hours ago
applyWatson Health - Quality Systems Engineer International Business Machines Corp. (IBM Corporation) - San Jose, CA, United States
International Business Machines Corporation provides information technology (IT) products and services worldwide. The companys Global Technology Services segment provides IT infrastructure and business process services, including outsourcing, process, integrated technology, cloud, and technology support. Its Global Business Services segment offers consulting solutions for strategy and transformation, application innovation, enterprise applications, and smarter analytics; and application management, maintenance, and support services. International Business Machines Corporations Software segment offers middleware and operating systems software, such as WebSphere software to integrate and manage business processes; and information management software for database and enterprise content management, information integration, data governance, data warehousing and analytics, business analytics and intelligence, and predictive analytics. This segment also provides Tivoli software for cloud and datacenter management, enterprise endpoint and mobile device management, asset and facilities management, storage management, and security systems; Rational software that supports software development; and Mobile Software for platform and application development, mobile security, and mobile device management. The companys Systems and Technology segment provides computing power and storage solutions; and semiconductor technology, products, and packaging solutions. Its Global Financing segment provides lease and loan financing to end users; commercial financing to dealers and remarketers of IT products; and remanufacturing and remarketing services for equipment. The company was formerly known as Computing-Tabulating-Recording Co. and changed its name to International Business Machines Corporation in 1924. International Business Machines Corporation was founded in 1910 and is headquartered in Armonk, New York.
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