Quality Systems Specialist in Norristown, Pennsylvania at Burlington Medical

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.