Principal Quality Engineer AIR

Olympus Corporation is a global medical technology company focused on making people’s lives healthier and safer. The Principal Quality Engineer will be responsible for managing complex projects within the Quality organization, facilitating process improvements, and ensuring compliance with regulatory requirements while collaborating with cross-functional teams.

Responsibilities:

• Supports the development and implementation of the global regulatory requests for additional information communication process and activities
• Supports and monitors the completion of regulator requests for additional information to the US FDA, and other Regulatory Authorities as applicable
• Supports and contributes in cross functional teams on investigating, assessing and authoring responses
• Tracks, trends, and analyzes requests for additional information from regulators, respective corrective actions, and remediations; provide inputs to upstream processes for improvements
• Gathers, collates, and maintains AIR weekly report; distributes and presents to internal stakeholders
• Identifies issues that require prompt notification and presents/communicates to Olympus senior leadership in a clear and concise manner
• Escalates potential safety issues for risk assessment or health hazard assessment
• Supports and contributes the development of Global AIR communications
• Works together with the Customer Quality organization to identify, access, and analyze data that have impact on the company’s compliance with overall quality systems
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Advise management on potential improvements or enhancement to quality systems and processes in the company
• Develops new approaches to solve problems identified as part of the team
• Participates in the implementation of Global Customer Quality initiatives and programs throughout the Global organization, as required
• Participates in the CAPA process as required as an assignee or project team member
• Perform other duties as assigned

Requirements:

• Bachelor's degree in a science, engineering discipline, or equivalent
• Minimum 10 years in medical device industry leading projects with a focus on process improvement and data analytics
• Proven ability to lead and manage cross-functional teams effectively communicate with all levels of management and drive effective change
• Requires background and familiarity with applicable regulatory requirements, including but not limited to U.S.FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA
• Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits
• Experience writing, reviewing, and providing feedback on requests for additional information or audit responses
• Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan) / company locations
• Experience working with, presenting, and communicating with executive leadership
• Experience with implementing tracking and monitoring tools
• Fluent in English language
• Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones
• International travel up to 20% of the time should be expected
• Strong Interpersonal Skills, Ability to manage complexity, analytical, people management on a global basis, office 365
• Ability to travel up to 20% of time domestically and internationally