The Quality Manager is responsible for driving the Quality & Regulatory vision and plans to execute company quality objectives, metrics, reporting and operating mechanisms, establishing & implementing regulatory best practices, technical standards, laws and regulations.
In this position, the Quality Manager will also be responsible for establishing and maintaining compliance of processes and products to the Quality Systems Regulations, ISO and other Regulation, as well as contributing to the development & implementation of commercialization of products in compliance with applicable regulations and standards.
The Quality Manager will manage and maintain compliance for quality systems, including: supplier control, equipment control, nonconformance control, CAPA, document control, training, production and acceptance activities.
Accountable for ensuring full quality and regulatory compliance of a facility including having solid QMS in place, while driving process effectiveness and efficiency at the site.
Ensures site audit readiness and hosts the Quality system audits, prepares and executes Quality management system reviews.
Proactive identification and alerting of Quality issues in time to resolve potential adverse effects to the customer.
Define approach and governance quality system internal audit program including training of auditors.
Drive continuous improvement of supplier Quality functional competence and maturity through coaching, mentoring and promotion of best practice.
Periodic reports to top management about Quality issues and analysis – MRB, CAPA, ECO's , internal and external audits, product and process performance.
Participating MRB, CAPA, ECO committees.
Responsible for incoming inspections, products final release.
Establishment and control of traceability system of company products.
Provide guidance for Design Control, Production and Servicing documentation to establish and maintain Design History Files and Device History Records.
Work closely with other departments such as R&D, Engineering, Operation and Service to achieve company goals.
Manage document control.
Manage the compliance of training activities and assure employee training remains up to date
