Quality Manager

Quality Manager

Hertfordshire

£45,000 - £50,000 + Benefits

The company

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.