Senior Manager, Global Quality Management System - Remote

The Senior Manager, Global Quality Management System is responsible for the global Quality Management Review. In this role, you will plan, coordinate, prepare and execute the global Quality Management Review at scheduled intervals and additional reviews as required. This will include following up on the management review to close identified actions and lead continuous improvement and completing all reports.

This role will partner close with other Quality and cross-functional leaders at site and global levels to assess the impact of changes to the Quality Management System and enable a timely completion of inputs to the Quality Management Review

Job Duties

• Participates in Quality initiatives as a cross functional contributor.
• Develops and fosters working relationships with colleagues globally to drive standardization, collaboration, and support growth across Olympus.
• Prepares content for each Quality Management Review. Ø Initiates and/or hosts a review of data prior to scheduled meetings.
• Completes reports as an output of Quality Management Review.
• Oversee the management of the Quality Management Review lifecycle including:
  • Plans the global Quality Management Review schedule and aligning with site/QMS level reviews
  • Coordinates content for Quality Management Review across site and global level including data from site level reviews.
  • Prepares content for each Quality Management Review. Ø Initiates and/or hosts a review of data prior to scheduled meetings.
  • Completes reports as an output of Quality Management Review.
  • Follow-up and tracking of outputs and actions for completion.
• Plans the global Quality Management Review schedule and aligning with site/QMS level reviews
• Effective Subject Matter Expert role for Management Review and tools in scope.
• Communicates with each site to promote and select escalated data for the global Quality Management Review.
• Demonstrates operational excellence and ensures quality in all deliverables.
• Fosters a culture of continuous improvement by identifying areas to improve, driving continuous improvement initiatives, and utilizing problem solving methodologies.
• All other duties as assigned.
• Supports audits as a Subject Matter Expert for Management Review, as required.
• Establishes metrics to evaluate QMR performance.
• Follow-up and tracking of outputs and actions for completion.
• Ensures functional groups adhere to the company’s Management Review procedures.
• Coordinates content for Quality Management Review across site and global level including data from site level reviews.
• Supports CAPA investigations & audit requests (internal & external).

Job Qualifications

Required:

• BS Degree in science or demonstrated equivalent professional experience.
• Travel to other company (regional) facilities may be required, up to 10%
• Travel to other facilities/locations may be required, up to 10%
• Minimum of 10 years Quality Management System experience required with demonstrated experience improving and/or maintaining quality management system (medical device is preferred) and preparing Quality Management Reviews.
• Ability to participate as a functional leader of a self-directed work organization and utilize the resources of the team.
• Having the global viewpoint to establish and maintain the QMS compiled with global requirements.
• Excellent understanding and working knowledge of appropriate global regulations, requirements and standards such as ISO 13485:2016, ISO 9001:2015 and FDA Quality System Regulation
• Minimum of 5 years of experience required in data analysis, trending and presenting data in a manner to drive informed decision making.

Preferred:

• Strong verbal and written communication skills, with the ability to interact with all levels of the organization.
• Ability to operate efficiently, proactively and effectively in a fast-paced environment.
• Excellent working knowledge of Quality Management Review.
• Strong attention to detail.
• Strong stakeholder management and ability to influence and coach others.

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