We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Completion and review of MPI documentation for all products in line with new regulatory directives
• Establish relationship with external manufacturers ensuring production targets are achieved.
• Completion and review of process risk analysis and ongoing dedication to risk reduction.
• Provide design for manufacture feedback/support to R&D team during new product development phase.
• Support equipment specification, procurement, calibration, and maintenance.
• Collaborate closely with component and service suppliers on any quality issues.
• Applies advanced statistical methods and performs mathematical calculations to resolve manufacturing processes, staff requirements, and production standards.
• Applies verbal and written communications skills in periodic and special reports and presentations both internally and with customers.
• Performs analytical problem solving/process improvement projects and utilizes structured decision making skills.
• Gives technical mentorship to junior engineers/technicians.

Education & Experience

• Mechanical or biomedical engineering degree or equivalent.
• Experience within a GMP regulated Operations Department environment.

Desirable
• Regulatory /Quality documentation writing experience highly favourable
• Production / line support experience within a medical device environment.
• Experience of technology transfer and process optimisation.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.