Exciting new opportunity for a Senior Quality Engineer with a top highly regarded company in Shannon, Co Clare.
This is a permanent full-time role with an attractive salary and benefits package on offer for the right candidate.
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. The successful candidate will interact with many different functional departments, suppliers, and experts 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.
Role of this position
- 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 nonconformance.
- 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.
- Bachelor's degree in Engineering or an alternative Bachelor's degree with certification as a Quality Engineer.
- 4+ years of experience in a Quality Engineering field.
- Experience working in a regulated industry, preferably medical devices.
- Knowledge on aspects of quality assurance techniques such as: inspection methods, statistical sampling plans, gauging and test methods concepts, validation, and statistical process control
- Experience with Microsoft Office Suite.
- Knowledge of process capability analysis and inspection methods.
- Previous supervisory experience desirable but not essential.
Please call Michelle Galvin today for further information on 091 373 938 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)