Kilkenny City, Kilkenny
CF Pharma Ltd
CF Pharma, a Leading Medical Device and Veterinary Nutrition Organisation are looking to attract a Quality Manager for their Business expansion. The successful candidate will have responsibility for leading and managing all aspects of the Quality Assurance and Quality Systems Management functions within the company. This role is part of the site management team and reports to the General Manager.
CF Pharma is located in Kilkenny City, with easy access to the M9 motorway.
Be the leader of Quality within the company. Manage and develop the Quality function. Continuously promote quality and customer satisfaction in everything that the company does.
Develop and implement effective and efficient Quality Management strategies, policies and procedures.
Ensure Quality Assurance and Quality Systems Management functions are fully compliant with customer, regulatory, legislative and business requirements.
Fulfil the role of management representative for the Quality Assurance and Quality Systems Management functions.
Ensure that customer requirements are understood and achieved for the lifecycle of the product.
Ensure supplier quality and customer qualification is effectively managed.
Lead quality related projects ensuring that they are delivered on time.
Ensure that continuous improvements to product quality and to the quality assurance and quality systems management are planned and implemented.
Drive preparation across the site for and manage execution of customer and regulatory audits.
Advise and promote best practice standards throughout the Company.
Manage document control, vigilance/surveillance, risk management, training, compilation of Annual Management Reviews
To take on other duties which the Company may assign you from time to time.
Degree qualification in Quality, Engineering, Science or relevant experience in a quality assurance role within the Medical Device Industry or similarly regulated environment.
Proven track record in leading the quality function within a medical device manufacturing company. A minimum of 3 years’ experience in a similar role.
Thorough knowledge of quality management systems and associated regulatory requirements (e.g. ISO 13485, HACCP etc.).
Demonstrated ability to project manage and execute tasks in an efficient manner.
Must be able to communicate at all levels of the organisation and with customers, suppliers and regulatory agencies.
Good interpersonal skills, team player, with a positive attitude in dealing with people.
Must be innovative and be driven to implement change to systems and procedures.
Understanding of lean principles. Lean green belt an advantage.
Excellent analytical skills. Ability to define problems, collect data, establish facts, and draw valid conclusions.
Permanent / Full-time