Quality Systems Specialist

Quality Systems Specialist

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 2535 lbs (documents, gages, samples).
• Perform repetitive keyboarding tasks with sustained focus and attention to detail using Microsoft software.