Principal Quality Engineer - FCA AIR

Working Location: MASSACHUSETTS, WESTBOROUGH 

Workplace Flexibility: Remote

 

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

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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.

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Our five Core Values empower us to achieve Our Purpose: 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus: https://www.olympusamerica.com/careers.

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 crossfunctional 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 FCA relatedrequests 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 FCA 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 FCA 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 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 sites/ organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.
• Knowledge of Recall, Field corrective action process and regulations.
• Understanding of Health hazard Evaluation process.
• Strong expertise in CAPA process and Root cause analysis.
• Experience using Excel or similar tools to perform data analysis.
• Knowledge of Medical device complaint handling and adverse event reporting process. 
• Experience writing, reviewing, and providing feedback on requests for additional information or audit responses.
• Experience working in a global organization and collaborating with