IBM Watson Health - Senior Quality Compliance Specialist in HARTLAND, Wisconsin

Job Description

The IBM’s Watson Health business unit is now looking for talented individuals ready to usher in the next era of healthcare. We live in a moment of remarkable change and opportunity. The convergence of data and technology is transforming healthcare and life sciences organizations in every way. IBM Watson Health uses Cognitive Computing to tackle some of health care most challenging problems - like revolutionizing how doctors research cancer or identifying new drugs to treat diseases.

Position: Senior Quality Compliance Specialist

Location: Hartland, WI (preferred) and open to remote

Job Description:

As a Senior Quality Compliance Specialist and member of the Watson Health Compliance Organization, you will lead and contribute to measurable improvements in complaint handling, post market surveillance, product safety, regulatory compliance and the customer experience. This role will work closely with cross-functional teams, including Technical Customer Support, Regulatory and Quality Assurance, Offering and Program Management, Engineering, R&D, Implementation/Installation, Returns, Field Service, Product Quality Assurance, Fulfillment, Legal and other stakeholders. Working cross functionally, you will support the Quality Management System, including: Corrective Action/Preventative Action (CAPA), root cause investigations, complaints, MDRs, Vigilance Reporting, Recalls and other post market surveillance processes. You will use your knowledge of global Medical Device regulations and standards to maintain compliance and continuously improve the Watson Health QMS.

Essential Responsibilities:

  • Provides leadership and guidance to other team members for the compliance and integrity of documented complaint files and the complaint handling process.

  • Serves as a Subject Matter Expert for functional areas within the QMS and the entire complaint handling process.

  • Assists Post Market Surveillance Management in ongoing post-market surveillance monitoring activities in compliance with FDA and other global medical regulations.

  • Under minimal supervision, works in conjunction with cross-functional team members to develop, implement, maintain, and improve the corporate quality system.

  • Ensures 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.

  • Contributes to decisions and improvements in complaint handling, product safety (Risk Assessments), product quality and the customer experience (Usability Assessments).

  • Assists in leading complaint review board (CRB) forums, assigns investigations to cross-functional team members, as necessary, and monitors the completion of tasks.

  • Reviews status reports with task owners and escalates to Post Market Surveillance Management when necessary.

  • Assists Post Market Surveillance Management in prompt escalation and completion of documentation for product safety complaints for potential Adverse Event &/or Vigilance Reporting.

  • Assists Post Market Surveillance management to ensure complaint documentation and records are complete and in compliance with Watson Health Imaging Procedures, Work Instructions and applicable regulatory requirements prior to closure.

  • Supports internal and external audits &/or inspections.

  • Leads investigations by performing research, documenting and reporting confirmed complaint trends to Post Market Surveillance Management.

  • When requested, assists in generating quality metrics and reports for Management at prescribed intervals.

  • Assists Watson Health Imaging personnel in the development and execution of streamlined business systems which effectively identify and resolve quality issues

  • Collaborates and guides Watson Health Imaging personnel with the development of improvements in QMS processes in conjunction with internal business partners

  • Utilizes problem-solving methodologies in identifying, scoping, prioritizing, communicating, escalating &/or resolving quality issues

  • Performs all duties and responsibilities as required by the Quality Management System Policies and Procedures or as assigned by immediate supervisor or upper management

Required Professional and Technical Expertise:

  • Minimum of 5 years in healthcare medical device or life sciences pharmaceutical experience

  • Direct experience handling complaints in the medical industry in an FDA 21CFR820, QSR compliant, and/or ISO 13485 certified organization

  • Experience participating in internal &/or external Quality Management System inspections

  • Able to work with and positively influence all levels of the organization

  • Analytical mindset with strong attention to detail and accuracy is essential

  • Experience with CAPAs, complaint investigations and root cause determination processes

  • Ability to quickly review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and lead presentations

  • Ability to lead and influence team members and cross-functional personnel in a demanding environment

  • Able to summarize information into presentations/reports and present to cross-functional personnel

Preferred Professional and Technical Expertise:

  • Strong technical/clinical knowledge of WH medical device software

  • Experience working with eHealth or software-as-a-device (SaMD), software-driven medical devices

  • Quality Engineering, Medical Device Software, Networking, IT &/or Software Development Experience.

  • Investigations, Root Cause Analysis, Risk Management (ISO-14971) and Usability (ISO-62366)

Required Technical and Professional Expertise

  • Minimum of 5 years in healthcare medical device or life sciences pharmaceutical experience

  • Direct experience handling complaints in the medical industry in an FDA 21CFR820, QSR compliant, and/or ISO 13485 certified organization

  • Experience participating in internal &/or external Quality Management System inspections

  • Able to work with and positively influence all levels of the organization

  • Analytical mindset with strong attention to detail and accuracy is essential

  • Experience with CAPAs, complaint investigations and root cause determination processes

  • Ability to quickly review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and lead presentations

  • Ability to lead and influence team members and cross-functional personnel in a demanding environment

  • Able to summarize information into presentations/reports and present to cross-functional personnel

Preferred Tech and Prof Experience

  • Strong technical/clinical knowledge of WH medical device software

  • Experience working with eHealth or software-as-a-device (SaMD), software-driven medical devices

  • Quality Engineering, Medical Device Software, Networking, IT &/or Software Development Experience.

  • Investigations, Root Cause Analysis, Risk Management (ISO-14971) and Usability (ISO-62366)

EO Statement

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.