Quality Systems Manager
Quality Systems Manager- Medical Devices- Galway
- Provide leadership and expertise in all aspects of Quality Systems.
- Ensure that the quality management system is managed, developed and implemented appropriate to the activities at the company.
- Develop and implement quality management strategies, policies and procedures.
- Ensure the business is in compliance with all regulatory requirements related to quality management.
- Day to day Leadership/Management of Quality Systems Team. Manage and develop the team through involvement, delegation, and regular reviews of performance.
- Management of key quality systems elements such as the non- conformance system, customer complaints and CAPA, risk management, validation, quality audit (internal and external), document control, calibration, supplier quality.
- Ensure the site is always “audit ready”, including preparation and successful achievement of all external audits from customers, regulatory bodies and third-party accreditation bodies.
- Manage all quality related aspects relating to new production introductions.
- Work with suppliers on quality related issues. Ensure all dealings are professional and good relationships are maintained at all times.
- Monitoring and reporting on trending metrics associated with the quality system.
- Fulfil the role of management representative for the Quality Management system.
- Actively participate in continuous improvement ideas, initiation, and implementation.
- Lead quality related projects ensuring that they are delivered on time and within budget.
- To take on other duties which the Company may assign you from time to time.
- Keep your skills current and be conversant with the latest developments which are relevant to the Company’s business.
Education and Experience:
- Bachelor’s degree in Science, Engineering, Manufacturing or related field.
- Thorough knowledge of medical devices quality systems (ISO13485/FDA).
- A minimum of seven years of relevant progressive experience within a similar environment, with five or more successful years in a leadership position.
- Strong leadership and people management skills.
- Thorough knowledge of quality management systems and associated regulatory requirements (ISO 13485, FDA etc.).
- 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.
- “Hands On” approach and mind set, with a passion for continuous improvement.
- 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.
- Demonstrable ability to achieve goals through collaborating, influencing and interaction at all levels across the business/function.