Job Title: Validation Engineer FTC
Reporting to: Engineering & Validation Supervisor
Division: Patient Monitoring & Recovery
Our client has an opportunity for a Quality Engineer to join the Tullamore team for a specific purpose contract supporting corporate engineering projects.
This role will work closely with our clients Quality and Engineering teams under the direction of the site MDR team.
The following elements will be required:
- Coordinate implementation of new materials to support the MDR requirements/remediation
- Support process and product validation executions ensuring validations meet pre-determined acceptance criteria.
- Critical Process validation protocols and reports - identify the critical validated processes. Provide validation reports that support the validation of the device manufacturing process, testing, and environmental controls.
- Root cause and problem solve production issues for Manufacturing Machines.
- Continuous improvement focus, demonstrating strong knowledge of Six Sigma methodologies and applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance.
- Continuously communicate status of projects and programs with regard to timing, objectives and roadblocks
- Work with cross functional teams to ensure objectives and timelines are being met
- Device Master Records - A thorough process assessment to ensure the process reflects the manufacturing process in line with the DMR
- Manufacturing flow charts -A detailed overview of the manufacturing processes Identifying any critical processes.
- Participate in our clients Risk Management program, identifying the critical to quality characteristics (CTQs) for each product code, quarterly updates to our risk management file
- A degree in Engineering / Technical discipline with minimum 3 years relevant quality engineering experience in a medical device/pharmaceutical environment.
- Process Validation experience essential
- Risk management training to ISO14971 is desirable
SKILLS & COMPETENCIES REQUIRED:
- Experience of working within a regulated industry with knowledge of MDD (Medical Device Directive), ISO 13485 /MDSAP (Quality Management Systems), FDA, cGMP, and Risk Management (ISO 14971)
- Experience working in a quality engineering role (preferably in a medical device setting)
- Experience on projects from conception to completion, cost savings and process improvements will be beneficial
- Knowledge of Six Sigma & Lean Manufacturing Techniques
- Quality Awareness and a proven track record of excellent quality standards
- Organised and resourceful with excellent attention to detail and ability to get the job done
- Ability to work with cross-functional teams, including production, quality, engineering, and materials.
- Effective communicator and influencer across multi-functional teams, with the ability to manage internal and external customers and corporate requirements
- Ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and the plant performance.
- The ability to take responsibility for own professional development and implement problem solving approach.
- Working knowledge with moulding/extrusion/automated assembly processes is advantageous.
- Commitment to work within the ethos of the company Mission, Medical Devices & Supplies Guide to Compliance and Quality Manufacturing and the guide to business conduct
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.