Title: Catheter Quality Leader
Description: The Catheter Quality Leader is primarily responsible for defining and implementing a tailored quality system for interventional imaging products, deriving from broader Siemens Healthineers and Ultrasound quality systems. Lead catheter regulatory and quality engineering teams throughout the product lifecycle (design, development, manufacture, and supply chain) helping deliver successful Catheter Product Programs. Influence and lead Quality initiatives as part of Catheter business line leadership team meeting and exceeding Product Life Cycle process compliance needs and quality goals.
Responsibilities & Expectations:
• Develops and implements regulatory strategies for new and modified ICE products
• Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
• Advocate and Champion QT charter driving continuous improvements in Product Quality and Process Adherence in Compliance with Industry Standards
• Represent the regulatory function on manufacturing and product development teams as a subject matter expert (SME) to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also recommends multiple solutions for selection by management.
• Prepare formal Regulatory Plans. Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
• Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans and leading teams to implement solutions.
• Review promotional material, labeling content, product and process changes, and product documentation to ensure regulatory requirements compliance, consistency, and accuracy.
• Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process
• Establish robust manufacturing processes/methods based on engineering principles; ensure completion of comprehensive process validations (IQ/OQ/PQ), including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion
• Develop and initiate training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Develop technical content of risk management files
• Lead in the investigation of simple to complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations, and develop reports
• Train, coach, and guide lower level employees on more complex procedures
The Catheter Quality Leader must have:
• Bachelor of Science in Engineering, Systems Engineering or related field.
• Minimum 7 years of experience as QE, Quality, Regulatory or Project Management in US FDA QSR and EU MDR regulated medical device company.
• Experience in class III medical device, preferably catheters or equivalent is a strong plus.
• Effective Influential Leadership, Clear Communication, Self-driven Cross-Functional abilities in a global environment is a must.
• Strong Product Design and Development experience. Working knowledge of risk management, hazards analysis, corrections and recalls, statistical analysis techniques is a plus.
• Experience applying ISO 14971/24971 standards to a complex product. Able to demonstrate working knowledge of QMS and understanding of Regulatory practices. Detailed working knowledge of 21 CFR 820, ISO 13485, IEC 60601-1, ISO 10555 standards.
• PMP, ASQ, CQE, Audits & Inspections and other certifications are a plus.