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Job Overview

We are looking for an individual to join our Quality Management System (QMS) team where they will assist with the day to day operations of the QMS and ensure it's compliance with the appropriate internal and external regulatory requirements.

Responsibilities and Duties

• Maintain document control, process change management plans and distribute hard copies.
• Maintain CAPA and Non-conforming (NC) Processes, training, timelines and metrics. Send status communications to the site teams.
• Provide technical support to owners, including identification of root causes, corrective actions, and implementation.
• Maintain internal and external audit process, schedule audits and initiate and assign non-conformances.
• Perform and/or provide support in internal and external audits within the company to ensure compliance to applicable regulatory and corporate standards/requirements and ISO.
• Compile, analyze and report quality metrics.
• Convey significant issues or developments identified during quality assurance audits and recommend process improvements to the Quality Management.
• Work across several departments with other personnel to obtain or share data; be willing to seek out and engage with others daily.
• Identify and recommend solutions to process to improve efficiency and quality of operations while reducing waste when possible.
• Participate in QMS training for new employee orientation.
• Other duties as assigned by manager.

• Three years' experience in a regulated environment, preferably medical devices or comparable regulatory controls
• Previous work experience in document control / document management
• Previous work experience investigating non-conformances, finding the root cause and applying suitable corrective actions
• Previous work experience in a cross-functional, team environment collaborating with different roles in a manufacturing environment
• Proficiency with computer systems, including MS Office applications.