Quality Specialist

VanTran Industries, Inc.•Waco, TX

14d•Onsite

About The Position

The Quality Specialist is responsible for reviewing and filing records for the Quality Department. This role may involve revising documents, organizing files, and assisting in the design of new systems. The specialist will support the development and maintenance of Quality Assurance systems and projects, ensuring compliance with regulatory requirements and ISO 9001 standards.

Requirements

Associate degree or Bachelor's degree (B.S.) from a college or university; or one-year related experience and/or training; or equivalent combination of education and experience.
Read, analyze, and interpret technical procedures and data.
Write reports and procedure manuals.
Effectively present information and respond to questions from management and co-workers.
Ability to multi-task and prioritize.
Strong time management and organization skills.
Demonstrate good judgment and decision-making skills.
Work with mathematical concepts such as probability and other statistical calculations.
Apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Working knowledge of internet programs and the Microsoft Office programs, including Microsoft Word, Microsoft EXCEL, and Outlook.

Responsibilities

Assist and support the organization's efforts to meet regulatory requirements and ISO 9001 conformity.
Assist in Internal Audits both as an individual and as a team member.
Assist the team in the preparation of reports, presentations, and Quality Assurance materials.
Assist in performing Gage R&R study.
Assist in maintaining all Supplier evaluations or assessments per the approved supplier list.
Assist in investigating product and supplier compliance.
Perform Document Control functions and assist all employees with questions pertaining to all aspects of that system.
Conduct special projects as needed.
Assist in maintaining the necessary active documentation as well as archiving of documentation as set by the facilities Quality System.
Assist with the CAPA process and perform CAPA Verifications.
Maintain metrics and communication board.
Assist in auditing of batch (DHR) records and manufacturing procedures.
Assist in writing standard operating procedures and forms related to operations.
Assist in the maintenance of the Quality Manual.
Assist with maintaining Master Device Records.
Maintain document control in QT9.
May perform Batch (DHR) Record Reviews.
Assist in investigations of failures, non-conforming products, and deviations.
Initiate disposition of defective products and materials.
Regularly evaluate monitoring equipment.
May participate in audits by regulatory agencies.
Assist in maintaining the Master Equipment Listing.
May perform calibration and verification of in-house production equipment.
Assist in managing the Calibration Process: Scheduling for outside calibration.
Maintain a clean and organized work environment.
Observe all company policies, rules, and safety practices.