Description
I have a fantastic job opening for a Quality Assurance Manager with a leading multi-national medical device company based in Galway.This is an excellent opportunity to join a top company in a senior management position that provides management support and leadership for Quality Assurance personnel and provides technical support for the manufacture of existing products and the design and development of new products.
SUMMARY OF DUTIES
- Manager who provides leadership, direction and management support to the Manufacturing Quality Engineering function.
- Provides technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies.
- Provides company with recommendations and decisions which uphold company and regulatory standards in furnishing quality products to the customer.
- Identify opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance or increase customer satisfaction.
- Promote and support the Business Excellence Program; lead by example. Partner with functional leaders to ensure that this program and the organization values are at the forefront of decision making and action.
- Partner with (Corporate) and other company sites in the development of partnership systems for standard business and quality processes.
- Perform a variety of management related tasks to ensure that quality improvements are achieved.
EDUCATION / EXPERIENCE:
- Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher); Post graduate diploma/Masters in Quality Management desirable.
- 10 Years (+) work related experience of which at least four years' experience is in the medical device manufacturing industry in a similar role, coupled with a proven track record in leadership and development of a large team.
- Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR) and JPAL/JGMP. Experienced in supporting external audits.
- Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower others.
- Excellent communication and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident, at all levels, internal and external.
- Passion for data, analysis, trends, reporting. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and work flows. Presents numerical data effectively.
- Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools.
If you are interested in hearing more about this excellent position please apply directly to this advert with an updated CV for immediate consideration or contact Derek Sheridan on for further information.