Job Description

The Quality Systems Specialist is accountable for maintaining and improving the effectiveness of the Quality Management System (QMS) at the operational level. This role owns execution of document control and quality record integrity for machine packets and related controlled records, ensuring information is accurate, accessible, and retained correctly. The Quality Systems Specialist drives daily system support for QC and production teams by standardizing workflows, eliminating record and documentation breakdowns, and continuously improving how quality information is created, stored, and used to prevent repeat issues. This position is expected to mature into broader QMS coordination responsibilities as systems stabilize and improvements are sustained.

Scope and Responsibilities:
Essential duties include, but are not limited to the following:

• Safety and Compliance: Follow all safety requirements and PPE rules while performing duties. Maintain orderly work areas and immediately escalate unsafe conditions or issues that could impact controlled documentation or record integrity.
• QMS Document Control Ownership: Own day-to-day document control execution for controlled quality records including machine packets, index sheets, accuracy books, and electrical schematics. Ensure records are accurate, complete, controlled, and retained per requirements.
• Quality Records Integrity and Standardization: Maintain consistent standards for how records are labeled, stored, scanned, and retrieved. Identify gaps, recurring errors, and breakdown points in the documentation flow and implement countermeasures to prevent rework and delays.
• Digital Record Management and Archiving: Manage the end-to-end process for ordering older machine packets from Vital Records, preparing packets for scanning, scanning packets and associated images, and ensuring proper electronic storage for long-term retention. Maintain orderly archives for both physical and digital records.
• Packet Build and Index Management: Maintain and update index sheets and supporting documentation used to generate machine packets. Ensure correct revision control and drive accuracy of packet content by coordinating updates and resolving inconsistencies.
• Document Change Support: Coordinate and support Document Change Requests (DCRs) by verifying completeness, routing, and record updates. Ensure changes are implemented into the controlled system so the shop floor and QC teams are working from current information.
• Defect and Material Documentation Control: Maintain controlled documentation related to defects and material records to ensure traceability, correct routing, and timely distribution. This role owns the documentation system and flow, not the investigation ownership.
• Continuous Improvement of Quality Systems: Proactively improve document control and record workflows to reduce time, errors, and disruption. Create or update work instructions, checklists, and standard work for recurring documentation tasks. Track issues, drive countermeasures, and sustain improvements through follow up.
• QC Operational Readiness: Ensure QC is equipped to execute daily work by maintaining stamps, forms, labels, supplies, and basic office equipment readiness. Resolve routine issues and escalate quickly to prevent disruption.
• Cross Functional Coordination: Coordinate with internal stakeholders to ensure machine manual USB drives and other required documentation items are received, sorted, and stored per the standard process. Communicate status and gaps early to prevent downstream issues.
• Records Retention and Disposal Control: Coordinate document destruction (shredding) in accordance with retention requirements and maintain documentation of disposal activities as required.
• Reporting and Visibility: Provide routine status reporting to QC leadership on record integrity, backlog, turnaround performance, recurring breakdowns, and improvement actions. Escalate risks early to prevent downstream disruption.

Education/Certification:
• High School Diploma or GED required. Additional education or training in quality systems, document control, or records management is preferred.

Skills:
• Strong attention to detail with the discipline to manage controlled documentation and record integrity.
• Strong communication and organization skills with the ability to coordinate across QC, production teams, and leadership.
• Strong PC skills including Microsoft Office and comfort working in digital filing systems and document repositories.
• Ability to standardize work, create clear instructions, and improve processes to reduce errors and rework.
• Ability to manage multiple priorities in a fast-paced environment while maintaining accuracy and follow through.

Physical and Mental Demands:
• Ability to work in a fast-paced environment where priorities may change.
• Able to sit or stand for extended periods while scanning, filing, or working at a computer.
• Ability to maintain attention to detail while handling controlled quality documentation.
• Must comply with required PPE and adhere to all safety regulations.