1895 Knowledge Manager
Duties:
The Knowledge Management Business Support Specialist will define the Knowledge Management and Business Process strategy, lead implementation, own tools & systems, and ensure a robust sustainability and maintenance plan for the PTD Device Development Group.
The Specialist will partner with the PTD Global Business Operations Knowledge Management team to ensure alignment to the current Knowledge Management infrastructure, objectives, tools & systems, and goals, in addition to preparing PTD Device Development for future state.
The Specialist will partner with regional (EU & US) device SME’s to ensure maintenance of the Business Process content, tools & systems.
The Specialist will be responsible for leading projects to improve information flow across PTD Device Development community, facilitating change management processes, partnering with customers to identify and develop efficient knowledge management processes & tools, leading change & communication efforts, and communicating and collaborating with key stakeholders.
The Knowledge Management Business Support Specialist will be a member of the PTD Device Development Business Operations Group.
This group plays a key role within the PTD Device Development organization to implement and maintain processes and systems to sustain knowledge and business processes, a quality mindset and compliance that enables for filing and inspection-readiness and retention of tribal knowledge.
Job Responsibilities
Participate in Continuous Improvement efforts to assess how existing Knowledge Management (KM) practices and tools can result in quicker and better accessibility of information for device teams with a focus on the processes.
Act in a liaison capacity with key stakeholder groups within and outside device development.
Translate and simplify the Knowledge Management strategy to allow for accessibility, usability, sustainability for everyday users.
Recommend the direction to be taken to enhance knowledge management and communications across groups and/or functions Own, manage and maintain the tools & systems associated with repositories, share sites, etc.
Skills:
Previous experience with oversight of an organizations Knowledge Management strategy, implementation, communications, and maintenance.
Experience in medical device or device combination product design and development environment preferred.
Experience in IT systems sustainability and maintenance preferred.
Knowledge of FDA CFR part 210, 211 & 820, ISO 13485, and industry technical standards relative to device development.
Understanding of international regulations and standards preferred.
Strong project management and organizational skills required.
Communicate with credibility and confidence.
Education:
Bachelor degree in communication, knowledge management or relevant experience, Knowledge Management Certification a plus.