Quality Engineering Manager

Job Description

Job Description

Job Description :

The QC Manager is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback. The ideal candidate would be responsible for the Quality Management System (QMS) of all Burlington Medical LLC, Bar-Ray Products and ProtecX facilities.

Duties :

• Acts as the primary representative for Burlington Medical, LLC and related companies for FDA and ISO audits / interactions.
• Evaluates, validates, and ensures regulatory standards met for all raw materials, most importantly, the radiation protection material.
• Responsible for supervising the Quality Site Leaders.
• Creates, maintain, and distribute data intensive reports related to quality i.e. (supplier performance, nonconforming material reviews) to upper management.
• Direct registration of any new medical devices, remove or update devices.
• Reviews submittal of any new medical devices into GUDID forward GTIN information to IT for upload.
• Oversee and guide all qualification and validation activities.
• Review supplier corrective actions for effectiveness.
• Identify, report, and escalate relevant Quality issues to management.
• Support production and operations relative to quality issues.
• Direct development, measurement and reporting of Quality metrics.
• Work with suppliers and production leadership to improve performance, implement processes and quality plans.
• Collaborates with Production Operations to ensure quality standards are in place.
• Responsible for the internal audit program and ensuring maintenance and compliance to ISO certifications and FDA regulations.
• Supports New Products Development projects.
• Leads the Quality Audit system by participating and leading internal audits.
• Manages the Corrective and Preventive Action (CAPA) system.
• Develops Quality Metrics, and coordinates quality data collection and analyses for Management Reviews.
• Recommends and implements potential improvements or enhancements to quality systems and processes.
• Leads Quality aspects of the Supplier Management process, e.g., participate and lead supplier audit.

Skills / Qualifications :