We are currently seeking a talented Quality Engineer to join our client and contribute to the success of their projects.
The Quality Engineer will be responsible for managing assignments that encompass entire projects or significant portions of major projects. This role involves determining and adapting methods and techniques to meet project variations, as well as coordinating phases of work both internally and externally.
The Quality Engineer will leverage Quality Engineering tools and practices for the efficient development, transfer, and maintenance of products and processes throughout the product lifecycle. Additionally, the role requires applying Quality Engineering principles and problem-solving skills to enhance and sustain products and processes, ensuring alignment with our overall Quality and Business vision.
- Key Responsibilities:
- Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Conduct benchmarking to develop more effective methods for improving quality.
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
- Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate. New Product/Process Introduction.
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
- Supports new product introduction as part of design transfer. Product Quality, Control & Disposition and Performance Standards.
- Conduct investigation, bounding, documentation, review and approval of non conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
- Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
- Skills Attributes & Experience:
- Bachelor's Degree, in Engineering or related technical field.
- Minimum of 2-4 years related experience working GMP Environment
- Experience working in both an FDA and European regulatory environment is desired
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a proven track record of implementing appropriate risk mitigation
- Strong knowledge of statistical software packages
- The ability to perform "hands on" troubleshooting and problem solving is preferred.
- Good technical understanding of manufacturing equipment and processes is required.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
