Senior Medical Devices Quality Engineer with experience in medical devices required by growing multinational in Galway city. Reporting to the Quality Operations Manager, you will lead a team of 6 in maintaining high quality performance standards within a Lean Six Sigma / FDA / ISO 13485 environment.
Responsibilities:
- Supervision and direction of a team of six
- Lead and drive QA initiatives
- 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 update 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
Requirements:
- Level 8 Degree in Science / Engineering or related fields
- Minimum of 5 years Quality Engineering experience in a medical device manufacturing environment
- 3 years experience in a senior quality engineering role
- Experience 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
