Job Opportunity:
We are seeking an experienced Quality Assurance Manager to lead our quality assurance agenda, ensuring regulatory compliance in target markets and managing a QA team.
Key Responsibilities:
* Develop and implement the company-wide quality assurance strategy and ensure customer requirements are met
* Establish and maintain a quality management system that complies with relevant standards
* Ensure design control for product quality and manage ISO14971 risk management
* Implement continuous quality improvement based on performance measurement and data analysis
* Secure regulatory clearance and maintenance for products in target markets
* Lead and manage the QA team and processes for product and service quality
* Represent the quality department in new product introduction (NPI) and new product development (NPD) activities
* Manage complaints and change control processes effectively
* Provide Regulatory Affairs support to customers and stay up-to-date with changing regulatory requirements
* Analyze and report data for management review
Required Skills and Qualifications:
* University degree or postgraduate qualification in Quality Assurance or a related field
* At least 8 years of experience in Medical Devices or regulated industries
* Significant experience in regulatory affairs and knowledge of international quality management systems
* Certified Quality Management System (QMS) internal auditor
* Knowledge of quality tools and methodologies, including lean six sigma and total quality management (TQM)
* Awareness of quality assurance processes and attention to detail
* Proven leadership skills and excellent communication skills
About the Role:
This is a unique opportunity to join our organization and make a significant impact on our quality assurance agenda. If you have a passion for quality and regulatory compliance, we encourage you to apply.