Telephone: 086 8395533
Senior Quality Engineer
Our client, a medical device company in Galway is currently looking to recruit a Senior Quality Engineer for their site.
The primary responsibility of this position is to assure conformance to established requirements and standards for products and processes through the effective implementation of the Quality Management System processes. This will entail directing and/or supporting the Quality Management System processes, including but not limited to Corrective and Preventive Action, Audits, Supplier Quality Management and Validation. Must interact with many different functional departments, suppliers, and experts outside of the company in order to communicate and implement Quality Objectives. This role will primarily support the Clean and Pack Business Unit which includes Final Cleaning, Biologic Upgrade, PMMA Coating and Sterile Packaging.
Principal Duties and Responsibilities
- Developing and implementing processes, procedures and instruction to sustain and improve the Quality Management System.
- Supporting Top Management in the development and implementation of quality systems strategies and objectives.
- Identifying and solving product and process problems
- Supporting various operational / manufacturing groups and suppliers in resolving and preventing quality issues.
- Performing quality engineering analysis and responses for corrective/preventive actions
- Working with suppliers, manufacturing, engineering, and other functional areas to assist and verify the implementation and effectiveness of the corrective/preventive actions taken for non-conformance.
- Conducting audits and assessments of internal processes and suppliers manufacturing sites
- Developing validation strategies and support the successful execution of same.
- Supporting and representing the site during external regulatory audits.
- This is not an exhaustive list of duties or functions.
Expected Areas of Competence
- Must be familiar with all aspects and elements of a quality system including but not limited to management responsibility, resource management, product realization and measurement, analysis and improvement processes.
- Knowledge on aspects of quality assurance techniques such as: inspection methods, statistical sampling plans, gauging and test methods concepts, validation, and statistical process control
- Demonstrated technical expertise
- Demonstrates ownership for the integrity of work
- Able to work independently or as part of a team and consider options for completing work
- Strong written and verbal communication skills
Education/ Experience Requirements
- 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
- Must have minimum of 5 years of experience in Quality Engineering field
- Experience of working in a regulated industry, preferably medical devices.
- Third Level Degree in engineering, Bachelor’s degree with certification as a Quality Engineer
- Excellent communication and influencing skills.
- Knowledge of process capability analysis and inspection methods.
- GD&T knowledge.
- Green belt
- Knowledge of quality systems regulations
- Process validation experience.
For further information on this Quality Engineer role in Galway please contact Bimi on 086 8395531 / email@example.com
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