Description
I have an immediate opening for a Quality Engineer with a fantastic medical device company based in Galway. This is a 12 month fixed term contract position. This is an excellent opportunity to join a company who are embarking on an exciting major expansion of the business with excellent opportunities for career progression on offer.The successful candidate will take part in multiple projects including a manufacturing transfer project which will involve Process Validation and Risk Assessment of the transferred production line and associated new equipment.
Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. This includes analysing quality trend data and taking appropriate action; supporting production on all quality related issues; investigating customer complaints; and ensuring an effective and robust quality system which complies with all relevant regulatory requirements.
General Functions -
* Formulates procedures, specifications, and standards for products and processes.
* Provides leadership for quality engineering projects from concept through design, implementation, testing, documentation, support, and maintenance.
* Develops and implements corrective/preventative action plans.
* Collects and analyzes data for gauge and product evaluation.
* Develop and maintain an effective and robust quality system which complies with all relevant regulatory requirements.
* Ensure all validation activity is effective and documented in a compliant manner.
* Complete in-depth investigations into customer complaints and implement corrective and preventative actions, as appropriate.
* Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products.
* Ensures that suppliers have necessary information and facilities to deliver quality products.
Skill Requirements -
* Process Validation and Risk Assessment.
* Expert knowledge of blueprint reading and geometric dimensioning and tolerancing.
* Understanding of QSR/ISO regulations
* Design assurance, FMEA, and product testing methods, and able to use optical comparators and CMMs.
* Knowledge of statistics, process control, and process capability.
* Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
* Facilitates team efforts on quality engineering projects.
* Ability to deliver, meet deadlines and have results orientation.
* Able to communicate both orally and in written form to multiple levels of the company.
Education / Experience
* Bachelor's degree in engineering is required or an alternative Bachelor's degree with certification as a Quality Engineer.
* Must be familiar with Microsoft Office Suite
* Accredited certification as a Lead Auditor
* Must have minimum of 5 years of experience in Quality Engineering field
If you are interested in hearing more about this position please apply directly to this advert or contact Derek Sheridan on for immediate consideration.