Kelly Services are recruiting for a Project Engineer for the County Offaly based medical device company.
The purpose of the position is to provide Quality Engineering (Process Validation) support, on an 18 months fixed term contract, to ensure the site product portfolio meet the new Medical Device Regulations. You will be coordinating in the development of process trials and validation requirements on new materials/ processes/ process changes by developing master validation plans & executing to plan.
KEY RESULT AREAS / KEY TASKS
Responsibilities will include, but are not limited to, the following:
- role will work closely with our 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
- Direct process evaluation and qualification as required. Support process and product validation executions ensuring validations meet pre-determined acceptance criteria.
- 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.
- 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.
- Participate in our 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 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 with active involvement within a manufacturing floor (preferably in a medical device setting)
- Experience in working on projects from conception to completion, resulting in significant cost savings and process improvements
- Knowledge of Six Sigma & Lean Manufacturing Techniques
- Quality Awareness and a proven track record of excellent quality standards
- Analytical, data and systems driven approach to problem solving
- Innovative and Proactive
- 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 new approaches/problem solving approach to doing things. Focused on simplicity of implementation.
- An excellent record of attendance and time keeping
- 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
- Experience working with moulding/extrusion/automated assembly processes is advantageous.
Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
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.