Our client a major a contract manufacturer here in Galway are looking to hire a Quality Director as they continue to grow.
As the Quality Director you will have full responsibility for all aspects of Quality performance and for the strategic direction of the company from a quality and regulatory perspective. You will will ensure that ‘best in class’ quality practices and systems are applied across the company while ensuring compliance with all applicable quality system regulations.
Provide strategic direction, leadership and expertise in all aspects of Quality and Regulatory Management.
Contribute to the achievement of the overall objectives of the company. Ensure effective execution of quality and regulatory organisational strategies and policies.
Develop and achieve annual operating plans for the quality function, aligned with the business AOP.
Ensure that quality strategies are aligned with the organisation.
Ensure that an effective and efficient quality management system, appropriate to the activities at the company, is implemented and maintained. Ensure compliance with all relevant quality and regulatory affairs requirements, including ISO13485, FDA, global Quality System requirements and other appropriate standards.
Implement appropriate metrics to ensure that the quality system is efficient, effective and utilised in a proactive manner to deliver competitive advantage.
To deliver on all budget (AOP) targets within the scope of quality and regulatory systems.
Work effectively with others to ensure that the quality function is both supportive and independent.
Manage resources and foster cross-functional teamwork to allow for Operational Excellence targets and Policy Deployment goals to be achieved.
Ensure that the Quality team has the required capabilities and competencies.
Responsible for the professional development of the Quality team. Support the Talent Management process to continuously improve performance and develop personnel skills and behaviors.
Accountable for Management Reviews – provide management with objective evaluation of overall quality and regulatory affairs performance and provide guidance for implementation of improvements.
Provide leadership to ensure the flawless launch of new products and processes into production.
Partner with customers and new product introduction teams in the development and introduction of new products and processes into manufacturing. Ensure that all product and services delivered by the company adhere to the various quality standards expected by our customers and the industry generally.
Partner with customers to pro-actively identify and resolve quality issues and ensure products are manufactured in compliance with agreed specifications.
Lead the supplier quality program, ensuring best practice supplier quality assurance approaches are implemented. Work with suppliers on quality related issues. Ensure all dealings are professional and good relationships are maintained at all times.
Educate all staff members on Quality Systems regulations and the impact of the regulations on their roles and responsibilities to foster ownership and ensure compliance with quality system procedures and regulations.
Fulfil the role of management representative for the Quality Management system.
Provide leadership to ensure compliance with the requirements of all applicable safety and environmental agencies, including Health, Safety, and Environmental Management System (HS&E) requirements.
Actively participate in continuous improvement initiatives, initiation, and implementation.
Lead quality related projects ensuring that they are delivered on time and within budget.
Be flexible and take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agreed with Management prior to any assignment.
Keep your skills current and be conversant with the latest developments which are relevant to the Company’s business.
Bachelor’s degree in Science, Engineering, Manufacturing or related field.
Thorough knowledge of medical devices quality systems (ISO13485/FDA).
Knowledge of LEAN and Six Sigma methodologies is desirable.
A minimum of ten (10) years of relevant progressive experience within a similar environment, with five or more successful years in a leadership position.
Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.).
Experience using SAP ERP software and Proficient in Microsoft Office Suite.
Demonstrable ability to achieve goals through collaborating, influencing and interaction at all levels across the business/function.
Strong leadership and people management skills.
Good interpersonal skills, team player, with a positive attitude in dealing with people.
Technical ability and acumen. “Hands On” approach and mind set.
Demonstrated oral, written and presentation skills. Must be able to communicate at all levels of the organisation and with customers, suppliers and regulatory agencies.
Trustworthy, discrete and a high degree of personal integrity to maintain sensitive and confidential information.
Must be innovative and be driven to implement change to systems and procedures.
Excellent analytical skills. Ability to define problems, collect data, establish facts, and draw conclusions.
Initiative and leadership skills.
Accurate and attention to detail.
Ability to work with limited supervision and lead a cross functional team.
For more information or a confidential discussion about this role please contact Michelle McInerney
091 706 717