Manager, Design Assurance

Job Duties

• Drive successful planning and implementation of global transformation initiatives needed to build and strengthen Olympus Design Assurance as a best-in-class industry-leading organization
• Establish and lead the Design Assurance Academy to develop and evolve skill/competency standards and syllabus within both NPD and Sustaining DA organizations
• Partner with the Global R&D Transformation Office to implement common technical and process enhanced training and curricula across Olympus DA and R&D Academies
• Establish DA communities of practice, training, toolsets and support for effective implementation and support of DA-owned processes and methods
• Responsible and accountable for leading projects and programs within the Design Assurance Quality space; develop, implement, and monitor strategic KPIs for Design Assurance globally and drive improvement via focused initiatives
• Leads Issue Escalation Process to identify, prioritize, and manage product issues globally as well as facilitate their investigation
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Identifies issues that require prompt notification and presents/communicates to Olympus senior leadership in a clear and concise manner
• Stakeholder and collaborator with Senior Leadership relating to project, process business and Quality strategies
• Supports audits by outside agencies (FDA, MDSAP) and acts as a subject matter expert to demonstrate compliance and continuous improvement to regulatory requirements and the Olympus Quality System
• Champion and subject matter expert for end-to-end customer and patient focused Design Assurance

Job Qualifications

• Bachelor of Science, medical, engineering, or scientific discipline required
• Minimum of 8 years of experience with a minimum of 4 years as a quality engineer within a drug/device manufacturer/distributor with a focus on QSR compliance and quality assurance
• Experience developing training programs and curriculum for quality and quality engineering topics or competencies such as Lean Six Sigma, Design Controls, Risk Management, Statistical Methods
• Experience in supporting sites/organizations through US FDA, Notified Body, and other International Regulatory Agency Audits
• Experience working with, presenting, and communicating with executive leadership
• Experience in problem solving, root cause analysis, and CAPA preferred
• Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan)/company locations
• Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (R&D, Manufacturing, Supply Chain, Regulatory, Quality)
• Proven leadership, teamwork, collaboration and influencing skills
• Ability to work effectively and with agility in a fast paced and dynamic environment
• Working knowledge of problem-solving skills, good statistical and analytical skills
• Strong written and verbal communication skills
• Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones
• Up to 40% domestic/international travel