Quality Systems Specialist (Newport News, VA)

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.

Location

Newport News, VA

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.