Senior Medical Devices Quality Engineer with 3+ years experience in a senior role required by growing multinational in Galway city. You will be responsible for the continuous improvement of the organisation’s Quality Management System and get the opportunity to work on exciting new projects.
Responsibilities:
- 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
- Supervision and direction of Quality personnel
- Other tasks as directed by the Operations Quality Manager in line with company goals and objectives
Requirements:
- Level 8 Degree in Science / Engineering or related fields
- Minimum of 5 years industry experience in a medical device manufacturing environment
- 3 years experience in a senior quality engineering role
- People management experience is critical – experience managing and leading a team
- Strong CAPA experience
- Strong root cause analytical and problem-solving skills
- Clear understanding of medical device quality systems and requirements, including measurement techniques, would be a distinct advantage
- Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable
- New product introduction and manufacturing process transfer experience desirable
- Demonstrated excellent organizational skills and ability to work on own initiative essential
- Excellent written and verbal communication skills essential
Please contact Emer Smith to discuss in confidence
00353578638188
emer@emtechrecruitment.ie
