Quality Engineer (Level I)

Caragh Precision is a medical device manufacturing company and a leader in the manufacture of precision engineered products for the top global medical device companies. It has over 100 CNC Machining Centres and assists in all stages of the product lifecycle from concept realisation to manufacturing. Based in Parkmore Galway, it specialises in Cardiovascular, Structural Heart and Orthopaedics.

The Quality Engineer is responsible for maintaining the QMS, working collaboratively and using clear communication. This role reports to the Senior Quality Engineer and works as part of the overall Quality Systems Team.

Responsibilities:

• Assisting in the maintenance of the QMS, ensuring compliance to ISO 13485, 21CFR Part820, and any applicable Medical Device directives.
• Incoming inspection and approval of raw materials
• Support Change Control processes and activities when necessary
• Generate e documentation within the QMS –
• Revising or writing procedures and process documentation when required
• Provide Quality assistance and feedback to all functions, such as Engineering, NPI etc.
• Calibration activities – both physical calibration and liaising with suppliers to provide contract calibration services.
• Review of calibration certification and requirements. Manage inventory of calibrated equipment
• Maintenance of the calibration schedule
• Documenting reports for measuring device non-conformance and determining containment measures and impact

Requirements:

• A 3rd level qualification preferably in Engineering although other STEMS subjects will be considered or a combination of education and relevant experience in the medical device or pharmaceutical industry
• Excellent attention to detail & organisation skills required
• Proficient in Microsoft Office applications e.g. Outlook, Word, Excel, Visio, PowerPoint, and Teams
• Excellent teamworking
• Proficient in English – written and verbal
• Strong communication skills (written, verbal and listening) across different functions and levels
• Innovative and continuous improvement mindset

Desirable / Advantageous

• Medical device manufacturing sector experience
• Lean/Six Sigma qualification
• Appropriate experience in a precision engineering environment
• ISO9000, ISO13485 experience

Location: Parkmore West, Galway

Job Type: Full-time, Permanent

Working Hours: Days - Monday to Thursday 7:30-16:30 and Friday 7:30-12:30 on-site

Benefits: Competitive compensation and benefits package

Job Types: Full-time, Permanent

Additional pay:

• Overtime pay

Benefits:

• Bike to work scheme
• Company events
• Employee assistance program
• On-site parking

Schedule:

• Day shift

Work Location: In person