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  • 1 month ago

jobs description

We are looking for enthusiasts

KVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries with a focus on quality. Headquartered in Basel, Switzerland, we have subsidiaries in Germany, the Czech Republic, Ireland, and Malaysia. With our enthusiasm for progressive technologies and our in-depth knowledge of industry best practices and regulations, we drive effective and efficient project delivery to keep our industry-leading clients ahead of the competition. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile, KVALITO works with reliable Technology Partners worldwide. For more information, please visit us at www.KVALITO.ch.

Life Science Consultant, Manufacturing Engineer

Location: Ballybrit, Galway

Role Purpose

The Manufacturing Engineer works as part of a multi-functional team supporting the implementation of EUMDR... registration of medical devices used for the treatment of stroke. This includes providing technical expertise within the manufacturing engineering team tasked with the production of acute ischemic stroke devices. Activities such as equipment validation, process validation, risk assessments and supporting regulatory and quality documentation at external manufacturer are core to the role.

Major Accountabilities
• Support the introduction of EUMDR certification of the suite of stroke devices
• 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 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

Minimum Qualifications And Experience


Mechanical or biomedical engineering degree or equivalent


English Native/bilingual proficiency

Work Experience

Minimum of 4 years' experience within a GMP regulated Operations Department environment

Hard Skills

Working knowledge of six sigma and/or lean engineering principles with a proven track record in use and delivery of results

Soft Skills & Nice To Have
• A strategic team-player, with deep-rooted initiative and accountability
• Inherent critical thinking and problem-solving skills
• Regulatory /Quality documentation writing experience highly favourable
• Production / line support experience within a medical device environment.
• Experience of technology transfer and process optimisation.
• Specific experience of laser cutting/welding & adhesive bonding

We Offer Great Benefits
• Flat hierarchies and responsibility from the beginning
• People-oriented culture
• Diversity and inclusion focused environment
• Global client projects in a multinational environment
• Flexible working hours and home office
• Involvement in global conferences
• Individual professional development, training, and coaching
• Unlimited full employment contract
• Excellent remuneration package consisting of a competitive salary plus a substantial bonus



If you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to recruiting(at)kvalito.ch including your:
• CV, cover letter and supporting documents (i.e., diplomas, certificates, references)
• Availability - earliest start date
• Salary expectations
• Location preference

We are looking forward to your application

Galway Ireland


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