Quality Systems Specialist

Burlington Medical•Norristown, PA

1d•$52,000 - $65,000•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

ISO 13485 preferred
Auditing experience or certifications (e.g., Internal Auditor ISO 9001/13485) a plus.

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.