£45,000 - £50,000 + Benefits
A global company who lead the way with innovative sterilisation control units in the Healthcare & Medical Device industry. Their products help save the lives of many people and the company is experiencing excellent growth. This is an excellent opportunity to work for an progressive & innovative company.
The Role - Quality Manager
The Quality Manager assumes overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards. You will follow the following Quality standards: ISO9001, ISO13485, MDSAP & FDA 21 CFR. This role will also focus on Supplier Quality, NPI and Quality Management System Compliance.
Responsibilities & Experience required
Lead the sites Quality staff to ensure compliance to the overall Quality Management System and to drive Continuous Improvement.
Provide coaching, mentoring and leadership to the Quality staff.
Serve as the Management Representative and lead the Management Review process.
Ensure compliance with appropriate domestic regulatory and international standards and requirements.
Lead the organization's product and/or service quality improvement process; including data analysis, improvement projects to improve key internal and external metrics.
Manage the complaint handling processes to ensure customer responsiveness and product and process improvements.
Determine supplier qualification risks based upon criticality of component and supplier process capability.
Combined experience in Manufacturing/Quality Engineering and/or Quality Systems.
Experience within medical device or other regulated industries preferred.
Experience working in an ISO certified environment required.
Experience within a Quality leadership role.
Please apply if this exciting opportunity to join a growing company within the Medical Device industry.