IBM Watson Health Imaging - Quality Systems Engineer in HARTLAND, Wisconsin

Job SummaryAs a Quality Systems Engineer and member of the Watson Health Compliance Organization you will support the Quality Management System, including: Design Controls, Corrective Action/Preventative Action (CAPA), complaints handling, production controls, supplier controls and post market surveillance processes. You will use your knowledge of global Medical Device regulations and standards to support premarket development and post market surveillance processes for Watson Health. This will include participation in program development, resolving CAPAs, complaints, MDRs, recalls and non-conforming products. You will interface with the Business and Marketing leaders, the solution teams, regulatory, legal and other stakeholders to maintain compliance for the QMS.Essential Job Duties:

  • Under minimal supervision, works in conjunction with team members to develop, implement, maintain, and improve the quality management system to ensure that the quality system is established and maintained in accordance with the requirements of the FDA and other regulatory agencies, certification bodies, and standards organizations.

  • Identifies and leads the development of improvements in QMS processes in conjunction with internal business partners.

  • Participates in the internal and external audit program to ensure ongoing compliance. Conducts audits as lead and/or supporting auditor per the audit schedule. Participates in FDA and other regulatory inspections.

  • Works closely with RA, QA, Designated Complaint Handling Unit and Support teams to ensure risk management activities are properly identified throughout the product life cycle.

  • Support the complaint handling program to ensure complaints are identified, processed, and investigated per internal procedures and regulatory requirements.

  • Support CAPA by working with cross functional team members to investigate and propose solutions to identified issues. Track CAPA investigations through completion to ensure identified nonconformances are corrected and recurrence prevented.

  • Establish and administer processes for receiving, documenting, tracking, post market surveillance processes (MDRs, recalls and non-conforming products) from customers and business partners

  • Partners with design and development to ensure products development activities follow quality management system procedures and work instructions.

  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

  • Apply Continuous Improvement methodologies to compliance processes, tooling and workflows

  • Review supplier qualifications, including participation in desk audits and/or on-site audits of suppliers as required.

  • Generates quality metrics and reports for Management Reviews at prescribed intervals.

  • Performs all duties and responsibilities as required by the Quality Management System Policies and Procedures.

  • Performs other duties as assigned by immediate supervisor or upper management

  • Bachelor’s degree in a scientific or technical discipline

  • At least 5-10+ years experience with job title/experience related to Quality Engineer, Quality Systems or Regulatory Affairs

  • Understands and implements the quality system in accordance with FDA QSRs, ISO 13485, MDD, and CMDR.

  • Excellent interpersonal, communication, and negotiation skills

  • Familiar with database entries and queries

  • Solid understanding of product development process and design control with emphasis on software medical devices

  • Proficiency with Microsoft Word, Excel and PowerPoint

  • Effective research and analytical skills

  • Effective written and oral communication, technical writing and editing skills

  • Ability to work independently with minimal supervision

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.