Quality Systems Specialist

Job Title:

Quality Systems Specialist Position Type:

Full Time Job Description Number:

JD65

Revision Date:

1/7/2026

Exemption Status:

Non-Exempt Approval Date:

Division:

Quality Approver:

Location:

Supervisor:

Job Description Administer and improve the company's Quality Management System (QMS) to ensure compliant, effective, and efficient operations. Maintain controlled documents and records, support internal/external audits, and generate quality metrics that drive corrective and preventive action and continuous improvement across the business. Key Responsibilities Maintain quality records (DHR/lot history, inspections, calibrations, training, audits, complaints) per retention and traceability requirements. Facilitate root cause analysis, track containment/correction/corrective actions, verify effectiveness, and close on time. Plan and conduct internal audits; support customer and third-party audits (e.g., ISO) by preparing evidence, escorting auditors, and managing responses and follow-ups. Maintain approved supplier documentation; assist with incoming inspection issues, and supplier change notifications. Log product complaints/feedback, route for evaluation, drive investigation actions, and maintain files through closure. Issue training assignments on new/revised documents; track completion and escalate past due items. Create NCMR's and track to completion. Compile weekly/monthly KPIs and present to Quality leadership; support Management Review. Maintain MRB (Management review Board) Participate in CI projects to improve safety, quality, delivery, and cost; standardize best practices and help sustain gains. Perform additional tasks as assigned to support quality and business objectives. Skills and Qualifications Working knowledge of quality system standards (e.g., ISO 9001;

ISO 13485

preferred) and basic regulatory concepts (records, traceability, risk, validation, calibration). Strong organization and attention to detail; accurate data entry and version control. Effective communication and facilitation skills across Production, Engineering, Supply Chain, and Customer Service. Problem-solving skills using structured methods; comfortable reading drawings/specs and basic measurement results. Ability to manage multiple priorities and meet deadlines in a fast-paced environment. Education and Experience A minimum of 6 years of experience dealing with quality systems or a Bachelor's degree in Mechanical, Manufacturing, or Quality Engineering with 2 years of experience dealing with quality systems. Auditing experience or certifications (e.g., Internal Auditor

ISO 9001/13485

) a plus. Physical Requirements Primarily office/computer work with routine time on the production floor. Sit/stand for extended periods; occasional walking, bending, or lifting up to 25-35 lbs (documents, gages, samples). Perform repetitive keyboarding tasks with sustained focus and attention to detail using Microsoft software.