Quality Manager

The Quality Manager will be responsible for implementing best practice initiatives to improve process capability, and will provide ongoing leadership across locations. As a departmental leader you are expected to be a role model in exhibiting the quality behaviours and values of the company and continuously fostering the development of others.

Responsibilities include:

• Implementation and maintenance of clauses and systems in compliance to ENISO13485:2016, 21CFR820 including all applicable elements regional requirements.
• Implementation, training and operation of a new eQMS platform for the management of all business management information.
• Management of Quality Personnel to ensure effectiveness in the delivery of site and departmental goals, including allocation of work and project management.
• Responsible for document and design change control process to ensure all changes are handled within the requirements of company protocol.
• Lead training and capability development, to assure focus on problem prevention as well as detection.
• Maintain reporting methodologies for Key Performance Indicators across all locations within scope.
• Response for collation of site management review for all sites to ensure continuous improvement of Quality Management Systems.
• Participate in our Risk Management program, identifying the true critical to quality procedures for each product, quarterly updates to our risk management files.
• Conduct product training, to build understanding of quality requirements in all levels of the organization through training and coaching activities.
• Execute internal audit process and participate during all third party audits.
• Execution of assigned projects (design and otherwise) within cost and schedule requirements including the company initiatives including six-sigma, lean, safety and cost reduction.
• The ongoing drive to improve LGC’s quality performance by use of CAPA, Kaizen, NCR using applicable root cause analysis methodology, with a specific focus on reduction of technical support issues and customer complaint reduction.
• Work with sister-organizations to develop best practices in all aspects of Quality Management.
• Manage all identified training and development activities as required including allocation of courses to determined timelines.
• Be available to travel nationally and internationally on requirement and to be able to function as back up to sister sites when required.
• Carry out additional duties that may be assigned to you.

Qualifications

• A degree in Quality Management / Engineering / Technical discipline or equivalent experience.
• ENISO13485:2016 Lead auditor IRCA certified.
• Risk management training to ISO14971:2019.

Skills and Competencies

• Experience of working within a regulated industry with knowledge of ENISO13485 (Quality Management Systems), FDA, and Risk Management (ENISO14971)
• 5 years’ experience working within as a quality manager with active within a medical device of IVD environment.
• Experience working within a medical software environment a distinct advantage
• Experience in a leadership role with people management responsibility
• Ability to work with cross-functional teams, including regulatory affairs, engineering and materials.
• Ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and the plant performance.
• Organised and resourceful with excellent attention to detail and ability to get the job done
• Clear written and verbal communication skills
• Energy and self motivation.
• The ability to focus on problem resolution in the organization.
• The ability to take responsibility for own professional development and implement new approaches to doing things. Focused on simplicity of implementation.
• An excellent record of attendance and time keeping