Principal QE Engineer QA/RA Compliance - External Audit

Job Description

Provide Quality Engineering support to ensure compliance with the Global Quality System regulatory requirements and the business strategy of the company. Represents Global QA&RA Compliance as a team member to support development and implementation Global external audit process, programs, and activities. Member of Global Audit Support Function established as a dedicated team to implement Global External Audit Process and provides all Olympus sites support for external audit related activities, improving outcomes and efficiencies. Can serve as a backup to the Director Global QA&RA Compliance, External Audit

Job Duties

• Global QA&RA Compliance team member that supports development and implementation of Global external audit process, programs, and activities. Leads or participates in the development of process and procedure development/changes. Provides guidance to other QE within the group.
• Provides support for all Olympus external quality audits and leads/supports the development of external audit training programs, resources, and tools, improving audit execution, outcomes, and efficiencies.
• Leads the development of external audit responses, facilitates completion, and delivery of responses to the US FDA, Notified Bodies, and other authorities. Supports the development and implementation of a Global audit response process.
• Supports the development and implementation of new monitoring and reporting tools that measure progress of external audit schedules and audit outcomes. Identifies, accesses, and analyzes data that have impact on the company’s compliance to overall quality systems. Tracks, trends, and analyzes external audit findings, corrective actions, and remediations. Make recommendations based on areas of highest compliance risk.
• Supports the development and implementation of Global audit readiness programs and tools that improve site audit readiness (compliance and audit support) and assesses likelihood of future audits. · Participant in Global External Audit Communities of Practice.
• 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. Assist in the implementation of Global QA&RA Compliance initiatives and programs throughout the Global organization.
• Participates in the CAPA process as required as an assignee or project team member

Job Qualifications

Required:

• Bachelor’s degree in engineering discipline or equivalent.
• Minimum of 8 years related experience and in medical device industry.
• 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.
• Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. Domestic and international travel up to 40 % of the time should be expected.

Preferred:

• Experience writing, reviewing, and providing feedback on audit responses, is highly valued.
• Interpersonal skills to develop and manage good working relationships with all Olympus locations and internal departments (R&D, Manufacturing, Supply Chain, Regulatory, Quality, Regulatory, etc…).
• Ability to work effectively in a fast paced and dynamic environment.
• Working knowledge of problem-solving skills good statistical and analytical skills.
• Strong written and verbal communication skills.
• Proficient in the use of Information Technology.