The Quality Engineer I will work within the Integra Lifesciences CSS Quality organization to support the process validation activities associated with the transfer of manufacturing of our range of Neurosurgical Medical Devices.
Working within the Manufacturing Transfer Quality team, you should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. You should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take actions, and have excellent written and verbal communication skills. The position will support the manufacturing transfer and qualification of existing product lines and new equipment as part of the development of a new manufacturing site, support supply chain concerns with existing products and components, as well as the risk mitigation aspects of product and process transfers between manufacturing sites. This position will have responsibility for developing and executing process and test method validation protocols to ensure the highest levels of product quality to the end customer. Being able to independently plan and conduct projects and/or assignments with technical responsibilities or strategic inputs with moderately detailed instructions from Leaders and Stakeholders is a must-have.
- Support process validations / qualifications for Medical devices in close collaboration with Manufacturing and external partners
- Support risk analysis activities. Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode effects analysis).
- Apply statistical methods and process excellence tools to establish validation and test plans as well as evaluate test data and processes.
- Proficiency in Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control
- Conducts and supports the development of test methods, process validation / verification, and product validation / verification
- Support transfer of manufacturing activities
- Manufacturing / Test Method procedure improvements
- Traveler / DHR improvements
- Ensure ERP system BOMs and Routes setup appropriately
- Contributes to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions
- Develop inspection methodology and acceptance criteria for sampling plans
- Provide support in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Nonconforming Materials, etc.
- Support supply chain issue resolution / product investigations
- Fulfill process control and validation requirements in accordance with company procedures, FDA and ISO guidelines
- Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Manufacturing, Regulatory, and Planning
- Understand manufacturing processes and recommend improvements where applicable