JD/41680
Engineering
Connacht Galway Galway city
Negotiable
5 - 6 Years
Permanent Full-time
Third Level Degree
Joe Dervan
joe@ccprecruit.ie
Quality Engineer
Our Client a medical device company in Galway is now hiring a quality engineer. The successful candidate will work as part of a team to maintain high quality / performance standards on all products. Reporting to the Quality Manager, the position will be challenging and will require an ability to work with minimum supervision.
Job Responsibilities:
· Overall responsibility for production GMP standards and compliance
· Investigating root cause of quality issues and following through on effective corrective actions to prevent re-occurrence.
· Establishing inspection standards, plans, frequencies and test methods.
· Performing an active role in further development of the quality management system. This will involve:
o Performing internal and external audits to ISO and FDA requirements.
Upgrading system elements as appropriate.
· 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 regulatory submissions.
· Develop strong links with customer organisations and other project stakeholders.
· Will have input and involvement in preparing customer project proposals
· Management New process validations and coordination of validation activates to meet project completion deadlines.
Key Requirements:
· 5+yrs industry experience in a medical device-manufacturing environment.
· Working knowledge of FDA and ISO Quality systems for Medical device companies.
· New product Introduction and manufacturing process transfer experience would be a distinct advantage
· Process validation experience including new process start-up, typically drafting MVP's, validation protocols and coordinating validation execution and FMEA activities
· Degree in Science or Engineering.
CCP Can Offer You
CV advice | interview coaching | tips & advice | CV advice | salary & benefits advice | career counseling | Career Direction - (full range of psychometric tools available)/Psychometric Testing Services/Occupational Personality Assessments (SHL Partner)
For further information please contact Joe Dervan at CCP Recruitment on 091 730022 or email joe@ccprecruit.ie
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