Description
Award winning company global medical device company is seeking a Quality Engineer to join their Quality team in their state of the art manufacturing facility in Galway.About the Company
The company has a huge global presence and its' Galway facility is to the forefront in driving its continued growth and success. The company is frequently recognized by its' customers for its unique partnership approach, exceptional product quality, reliability, delivery performance and customer service. The progressive and forward thinking culture at the company drives standards and ensures great career development opportunities are within everyone's grasp.
About the Role
The successful candidate will have overall responsibility for production GMP standards and compliance. They will be tasked with investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues. Establishing inspection standards, plans, frequencies and test methods and establishing and maintaining FMEA's will also be a key duty for this role. The job requires the successful candidate to prepare and update operations procedures and associated documentation. Some of the other duties and responsibilities involved in this job include:
- Reporting area of responsibility metrics.
- Supporting customer and surveillance accreditation audits.
- The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
- Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
- Maintain relevant documentation to comply with quality standards and customer requirements.
- Develop strong links with customer organisation's and other project stakeholders.
- Quality review of responsible area validation documentation.
- Performing an active role in further development and continuous improvement of the quality management system.
- Support Operations area projects and initiatives i.e. Kaizen, CFPS, etc.
Requirements:
Ideally the successful candidate will have be educated to a degree level in science or engineering with 3-4 years industry experience in a medical device manufacturing or pharmaceutical environment. It is preferable that the candidate has a working knowledge of FDA and ISO Quality systems for medical device companies. It would be a distinct advantage is the candidate has new product introduction and manufacturing process transfer experience. It is also desirable if the successful candidate has quality experience in component and device manufacturing. Excellent written and oral communication skills are essential for this Quality Engineer job.
Are looking for a new challenge? A chance to join a thriving global company that continues to go from strength to strength? This is the role the role for you! Please apply below with an up to date CV.
No CV? Not Sure Yet? Give me call for more info and an opportunity to ask more questions Barry Smyth !