Senior Quality Engineer - Galway. Fabulous permanent Senior Quality role to take responsibility on bringing a new Product line in from the US. This role will take ownership of the product line set up and operation of this new line.
With 6 direct reports People Management and proven leadership experience is essential along with the ability to see the bigger picture from a business perspective.
Apply today to RT Lane Recruitment for an immediate response on this business critical opportunity.
- Manage the day to day activities of the team in a safe environment and be responsible for Health and Safety goals.
- Deliver on all KPIs that help the business achieve its goal.
- Lead and drive QA initiatives within area of functional responsibility.
- Provide Quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions.
- Lead, coordinate & maintain risk assessment documentation e.g. FMEA’s..
- Investigate root cause of Quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.
- Strategically lead new product introduction and contract reviews from a QA perspective.
- Prepare and updating Operations procedures and associated documentation.
- Overall responsibility for functional area GMP standards and compliance including the promotion of Quality awareness.
- Establish inspection standards, sampling plans, and test methods.
- Report Quality metrics.
- Develop strong links with customer organisations and other project stakeholders.
- Quality review of functional area validation documentation.
- Perform and support internal and external audits to ISO and FDA requirements.
- Perform an active role in further development and continuous improvement of the Quality Management system.
- Level 8 degree in Science / Engineering or related fields.
- Minimum of 5 years industry experience in a medical device manufacturing environment.
- People management experience.