Our client is seeking a dynamic senior leader to oversee their quality system.
As the senior quality manager, you will lead the design and development of quality control measures to ensure our products meet industry standards. Your role will involve implementing ISO standards and managing all aspects of Quality and Regulatory activities.
Responsibilities:
-Develop and maintain our Quality Management System.
-Prepare for ISO certification completion by April 2024.
-Manage a team consisting of 1 Quality Manager, 1 Lab Supervisor, and 4 QA Supervisors.
-Participate in material review board (MRB) reviews to address any issues.
-Oversee change control for business operations and manage CAPA programs.
-Generate QC metrics reports.
-Manage corrective and preventive action (CAPA) system.
-Supervise all quality assurance, regulatory, and validation activities for QC and production.
-Support customer audits and answer technical queries.
-Prepare for and support internal QMS surveillance and certification audits.
-Collaborate with the team on annual audits to meet ISO requirements.
-Direct PPAP and APAQP activities throughout the company.
Qualifications:
-Minimum of 5 years of experience in Manufacturing Quality Leadership.
-Background in manufacturing medical devices.
-Bachelor's degree in Engineering, Quality, or related field.
-Familiarity with ISO and FDA manufacturing regulatory standards.
-Direct experience with performing PPAP.
-Experience developing FMEA and Control plans.
-Effective communication skills for internal and external relationships.
-Knowledge of data quality management tools.
-Certified Quality Auditor preferred.
-Six Sigma Black or Green belt desirable.