Quality Systems Specialist

 

Position Overview

The Quality Systems Specialist is responsible for supporting, maintaining, and continuously improving the Quality Management System (QMS).This role supports quality system processes including document control, training, change control nonconformance, and CAPA activities. The specialist monitors quality metrics, assists with audits, and ensures compliance with applicable global regulations and standards with a specific emphasis on ISO-13485 and FDA 21 CFR 820.

Essential Job Functions and Responsibilities

· Support monitoring and continuous improvement of Quality Management System processes.

· Collaborate with Engineering, Manufacturing, and Quality teams on the development and sustaining of quality processes.

· Support internal and external audit preparation and execution activities.

· Monitor and trend Quality Management System nonconformances and quality data for escalations.

· Drive training activities and tracking to ensure compliance with all applicable regulations and key performance indicators.

· Assist with generation, analysis, and presentation of quality metrics.

· Support the Corrective and Preventive Action (CAPA) program, including coaching CAPA owners, drive comprehensive and audit-ready investigations and effectiveness checks.

· Support document control activities, including review, approval, and change management within the electronic QMS.

· Track and assess new or revised external standards and regulatory requirements ensuring that involved processes are maintained for continued compliance.

· Ensure adherence to company procedures and applicable regulatory and quality standards.

· Maintain effective working relationships with internal and external stakeholders.

· Support additional quality system activities as assigned.

Required Qualifications

· Bachelor’s degree in engineering, medical, science, or equivalent experience. . Previous experience in the role can be considered.

· Minimum of 3 years of experience supporting quality systems within a regulated environment.

· Prior experience in the medical device field is required; preferably experience with disposable and capital equipment medical devices. Ability to work effectively in a fast-paced and dynamic environment.

· Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers.

· Fluent in English (written and verbal).

Desired Qualifications

· Strong interpersonal skills and ability to work cross-functionally.

· Self-motivated with strong organizational skills.

· Strong written and verbal communication skills.

· Lead Auditor Certification preferred.

· Certification or training in Lean Six Sigma is a plus.