Role Summary:

Problem solver who takes initiative to address compliance and business-related issues. Develops and supports continuous improvement loops systems for Quality ecosystems. Provides oversight, evaluation, and corrective action of assigned issues. Assist in the process of gathering, interpretation and application of statistical methods to various Production/Quality related processes and communicate those through reports, memos, files and presentations. Responsible person for Quality Tracking System (Trackwise) records such as investigations, CAPA, change management and action items.

Role Responsibilities:

• Solve problems and improve business processes while ensuring compliance with company procedures, quality standards and government regulatory requirements.
• Identifies and implements quality improvement and process/continuous improvement ideas, specifically process capability, workflow and compliance improvement projects.
• Analyze data from throughout different stages of production to determine control over applicable variables. Create visual outputs to facilitate continuous improvement discussion.
• Coordinates activities cross functionally (QA, Operations, Planning, Laboratories, etc.) to ensure appropriate prioritization of deliverables for applicable CI projects.
• Reviews/approves and participates in change notifications, issues/investigations and corrective actions.
• Ensure compliance with company procedures, quality standards and government regulatory requirements.
• Responsible for review, redline and changes for controlled documents.
• Participates on teams and provides guidance and direction from a Quality/compliance perspective.

Basic Qualifications:

• Bachelor’s degree in a scientific/engineering discipline required.
• 3-5 years of cGMP, FDA regulated industry experience; prefer experience within the medical device or Quality Engineering settings. 1-3 years of experience with a Master’s degree acceptable.
• Knowledge of computerized systems (MS Office suite).
• Demonstrated ability to perform data analysis
• Demonstrated ability to manage multiple priorities
• Professional certification is recommended (i.e. CQA – Certified Quality Auditor, CQE – Certified Quality Engineer, SQE – Software Quality Engineer, etc.)

Meridian Medical Technologies (MMT) is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. MMT also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

MMT requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, MMT will consider requests for Reasonable Accommodations.