Principal Quality Engineer – FCA AIR

Role Overview

• 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.
• Supports the development and implementation of the global regulatory FCA related 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 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.

Requirements

• 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 multiple regions (Americas, EMEA, APAC, China & Japan) I company locations
• Experience working with, presenting, and communicating with executive leadership
• Experience with implementing tracking and monitoring tools
• Fluent in English language
• Strong Interpersonal Skills, Ability to manage complexity, analytical, people management on a global basis, office 365
• Ability to travel up to 10% of time domestically and internationally.

Benefits

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance*
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**