Director Global Quality, Aortic

Position Objective:

This position utilizes Quality Engineering, Risk Management and Quality Assurance techniques and expertise to provide management and functional support for new product development and product line support for US Aortic stent graft products manufactured in Europe. This position also ensures that the company complies with all applicable federal, industry, and corporate procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products for US and Europe.

Ensures that all areas outlined under "Principal Responsibilities" are accomplished in an efficient and professional manner to support Artivion, Inc.

Position Responsibilities:

• Manages the US and Hechingen Quality Engineering NPD teams.
• Learn JOTEC and Artivion Quality Management Systems and technical documentation.
• Manages robust risk management processes for US and EU aortic programs.
• Align Artivion current QMS towards all requirements to market class III implantable cardiovascular devices.
• Defining, implementing, and improving assigned Quality program and governance, with gap analysis to FDA requirements.
• Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System for both US and Europe.
• Interprets government regulations, agency guidelines, and internal policies to assure compliance for Europe and US.
• Partners with Subject Matter Experts to drive development of clear objectives for education packages that improve competency.
• Program management responsibilities may include planning, resourcing, providing status for, resolving issues, and identifying project risks for multiple work streams.
• Ensures results meet requirements regarding technical quality, reliability, schedule, and cost.
• Consults on development of quality improvements and recommends alternatives. Guides the architecture, governance, and measurement of assigned programs. Manages the development and implementation of system level improvement plans across a variety of areas to increase efficiency, reduce cost and streamline operations.
• Demonstrates excellent technical writing when authoring assigned Product Risk Assessment, Health Hazard Analyses, Post-Market Surveillance Reports. Facilitates Design FMEA and Risk Management File updates on assigned product lines.
• Create, review and approve Protocols, Process and Product
• Create, review and approve documents required for the Design History
• Leads or owns in corrective/preventive action teams to resolve systemic issues. Partners with cross-functional peers to resolve product performance issues (NCMRs, CAPAs, deviations, manufacturing process problems etc.) to assess impact on device quality and product availability.
• Oversees and manages the operational aspects of ongoing Aortic product development projects. Monitors the project from initiation through delivery. Reviews status of projects and budgets; manages schedules and prepares status reports. Assesses project issues and develops resolutions to meet productivity, quality goals and objectives.
• Partners with multiple manufacturing sites and external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance. Helps create qualification strategies to implement complex changes.
• Perform Internal or Supplier Quality System Audits, as assigned.
• Develop Validation Master Plans and Validation Project Plans to ensure that all validation tasks required supporting operational areas and corporate projects are identified and completed within established time frames.

Qualifications:

• Bachelor's Degree in Engineering, Science, or Technical field with 5+ years of experience in quality, engineering, operations and/or program management or Advanced Degree in Engineering, Science or Technical field with 3+ years of experience in quality, engineering, operations and/or program management
• Experience with cardiovascular implantable medical devices
• Knowledge and experience in application of statistics and lean sigma principles
• Knowledge of cardiac anatomy, physiology, and primary disease states
• Working knowledge of 21 CFR Part 820 (Quality System Regulation), ISO 13485, EU Medical Device Directive, MDSAP and relevant international standards
• Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, DFMEA)
• Demonstrated ability to work in a matrix organization and positively influence strategy and outcomes
• Ability to deliver on multiple projects simultaneously, and balance between long- and short-term priorities
• Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
• Excellent problem-solving skills, including demonstrated application of structured problem-solving methods and tools
• Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
• Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others' needs, negotiate for win-win, own the whole)
• ASQ, CQE, CQA Certification preferred, but not required.