Quality Assurance Compliance Engineer

ZOLL Medical Corporation•Chelmsford, MA

3d•$90,000 - $110,000

About The Position

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won’t just have a job. You'll have a career—and a purpose. Join our team. It’s a great time to be a part of ZOLL! This individual will drive Quality Improvements through the Corrective and Preventative Action program in a cross functional environment. Support the Organizations Internal Audit program and participate in external audits to ensure we maintain regulatory compliance. Assist with content review for Quality System documents and regulatory communication.

Requirements

Four-year degree required
Minimum 5 years related experience in a regulated environment
Excellent written, verbal and interpersonal communication skills
Proficient time management and project management skills
Experience with FDA QSR, ISO13485, MDD and MDR, MDSAP and ISO14971 for Medical Devices
Proficient with auditing techniques

Nice To Haves

Medical Device Industry preferred

Responsibilities

Review CAPA(s) for appropriate content
Monitor and Manage CAPA KPl(s) to objectives
Ability to lead a cross-functional team through CAPA
Maintain and look for opportunities to continuously improve the CAPA process and compliance to all applicable regulations
Conduct appraisals program yearly or as needed for CAPA Leads
Assist in the development, training and expectation for CAPA Leads
Assist in the management and scheduling for Internal Auditing
Ensure internal audit finding response time meets internal targets
Ensure timely closure of internal audit responses
Participate in external audits related to manufacturing site under QMS umbrella
Ensure timely QS compliance related to SOP review
Assist in the review of Health Risk Assessment's
Assist in the development and review of Competent Authority, Registrar and Regulatory Agency correspondence
Support managers and supervisors to define training requirements and ensure employees are trained to adequately perform their assigned responsibilities related to the Quality Management System.