Principal Quality Engineer AIR

Working Location: NATIONWIDE 

Workplace Flexibility: Field

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

​

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

​

Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

 

 

Job Description

The Principal Quality Engineer is responsible for driving complex projects to completion by effectively managing all aspects related to such initiatives within the Quality organization. Primary focus will be on facilitating cross-functional team process improvements, developing actions, and tracking, where needed, to meet defined objectives while satisfying regulatory requirements and business strategy.  This position requires a global outlook and the ability to integrate many different aspects of the organization, such as functions, departments, software platforms, etc. to ensure the project satisfies various stakeholders and areas of the business.

Job Duties

• 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.

Job Qualifications

Required:

• Bachelor’s degree in a science, engineering discipline, or equivalent. 
• Minimum of 9 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 sit