Job Description
Job Description
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.