Quality - Quality Assurance Specialist

Job Overview:
The Quality Assurance Specialist provides a high level of support to the Quality Department to maintain the effectiveness and continuous improvement of the Site Quality Management System (QMS). Works to ensure compliance with ISO, customer, and regulatory requirements through coordination, documentation, training, and audit support.

Duties and Responsibilities

Coordinates and conducts audits, including closing out audit findings, creating audit finding reports and determining proper corrective and preventive actions.
Creates and maintains company compliance documentation, such as manuals, instructions, and procedures. Acts as the Document Control Coordinator.
Actively participates in development of audit / inspection plans, risk assessments, gauging, customer, and regulatory requirements in conjunction with management, engineering, and external consultants.
Provides for administrative support to the QMS of the organization, including coordination of ISO audit information and data gathering, procedures, etc.
Directs the work of site personnel to ensure that written procedures for the QMS are in proper format, revisions are handled following proper processes, QMS database is maintained, and records are organized and properly stored.
Supports the site to ensure that products and processes comply with the regulatory requirements of the QMS. Coordinates activities of all other personnel who are assigned to audit, inspect, and train to the management system requirements.
Ensure all employees receive proper training to ISO regulatory requirements.
Purchases the QC laboratory materials, supplies, and equipment.
Acts as the Calibration Coordinator.
Acts as a back-up to QA Lab Technicians as needed.
Performs other duties as needed.

Knowledge, Skills, and Abilities

Strong understanding of quality inspection, measuring, and testing equipment.
Knowledge of ISO 9001 Quality System requirements.
Familiarity with PPAP (Production Part Approval Process), APQP (Advanced Product Quality Planning), PFMEA (Process Failure Modes and Effects Analysis), and problem-solving tools (8 Disciplines, 5 Whys, Fishbone diagram, Process mapping).
Ability to read and interpret engineering drawings, including geometric dimensioning and tolerancing.
Excellent computer skills, including proficiency in Office 365.
Strong organizational skills with the ability to manage multiple assignments simultaneously.
Sound judgment and proactive approach to problem-solving.
Effective communication and teamwork skills.
Ability to manage multiple priorities in a manufacturing setting.
Ability to transfer knowledge of policies and procedures.

Education and Experience

High School Diploma or equivalent required
Bachelor’s Degree, or minimum 5 years of experience in manufacturing and/or management experience, or an equivalent combination required.
Two or more years of experience in a QA support role preferred.
Experience in ISO systems preferred; ISO Internal Auditor training a plus.

Physical Requirements
Frequent exposure to manufacturing operations requires the ability to use all necessary safety equipment. Standing, walking, stooping, and bending are frequent and required. Must be able to tolerate repetitive motions for extended periods of time. Must be able to lift to fifty pounds. The ability to stand for at least 8 - 12 hours on a concrete surface is required. Must be able to tolerate extreme temperatures.