Join our dynamic team as we seek an experienced quality assurance leader to oversee our quality operations in the healthcare and medical packaging sector. Your responsibilities will include:
Guiding the Quality Management System (QMS) implementation for medical packaging products
Facilitating adherence to ISO 13485, ISO 15378, and FDA cGMP standards
Ensuring teams are prepared and excel during audits through robust quality processes
Managing CAPA processes, performing root cause analysis, and driving corrective actions
Collaborating with suppliers and cross-functional departments to embed quality in every facet of operations
Providing mentorship and leadership to foster continuous improvement among quality team members
Ideal candidates will have:
Demonstrated experience in regulated manufacturing environments such as medical device, pharmaceutical, or medical packaging
Exceptional leadership skills and proficiency in quality systems
Hands-on expertise in audits, CAPA management, risk management, and supplier quality
In-depth understanding of ISO standards and FDA regulatory frameworks