Quality Engineer

Key Responsibilities: 1. Process and Product Development: · Develop new processes/products and revise existing ones. · Create and update project-specific quality plans, ensuring adherence to customer requirements. · Work as part of a cross-functional team. · Develop methods to measure products to ensure they meet quality standards. · Troubleshoot measurement methods and equipment to ensure accuracy and reliability. 2. Validation: · Lead validation of new products and technology (IQ, OQ, PQ). · Act as QA lead for equipment validation. 3. Customer and Supplier Interface: · Collaborate with customers and suppliers on new product processes. · Lead customer complaints and supplier SCAR management. 4. Statistical Analysis: · Compile and analyze statistical data to assess process capabilities. · Conduct PFMEA, GR&R, and SPC studies. 5. Quality System Documentation: · Create and maintain quality system documentation, including quality plans, inspection and control plans, and work instructions. 6. NCR and CAPA Management: · Manage NCR, CAPA, and customer complaints from creation to closure. · Use problem-solving tools and work as part of a cross-functional team. 7. Change Management: · Lead changes in production, ensuring compliance with customer agreements, ISO standards, and internal requirements. · Prepare, submit, and follow change requests (SCR) with customers. 8. Production Support: · Assist production in achieving APU objectives. · Generate quality KPIs for PSM2. 9. Audits: · Perform internal and external audits. 10. Secondary Responsibilities: 11. Backup Support: · Serve as backup for other QEs on customer or internal tasks as requested by the Director of Quality. 12. Continuous Improvement: · Identify and support continuous improvement opportunities. · Participate in LEAP workshops. 13. Training: · Contribute to employee training. 14. Other Duties: · Perform other duties as assigned. Note: The Quality Engineer has a functional link with the QAR/QA inspectors. In case of any issue escalated by the QAR about the DHR final acceptance and/or final CoC, the QE has authority to release or hold the DHR, approve the final CoC and/or decide the final status of the parts and release or hold the batch. They can also escalate to the Director of Quality. Required Qualifications: · Bachelor degree in Manufacturing Engineering or related field. · Minimum two years relevant experience / five years for senior position. · Blueprint reading is mandatory – GD&T level expected · Experience developing manufacturing quality plans. · Experience conducting process capability, GR&R, PFMEA and SPC studies. · Experience working on NCR / CAPA. · Experience working in an ISO environment, preferably ISO 13485. · Proficient PC skills in a Windows environment. · Effective written and verbal communication skills. · Strong interpersonal and teamwork skills. Preferred Qualifications: · Experience in a precision machine shop environment. · Experience optimizing processes to achieve ongoing cost reductions. · LEAN / Six Sigma training and demonstrated application. · Demonstrated use of structured problem-solving methods (i.e. 8D). · Experience in internal and supplier audits. · Experience using an ERP system. · Experience of managing a staff or cross functional team lead for senior position Physical Demands · Must be able to sit, grasp items and perform keyboarding frequently. · Must be able to reach, stretch and occasionally lift up to 30 lbs. · Must be able to travel occasionally. Sensory Requirements · Normal vision. · Normal hearing. · Ability to communicate verbally. Health, Safety & Environment responsibilities and skills: · Participate in the development and promotion of the HSE culture · Be exemplary in terms of health, safety and the environment, in particular by : o Respecting and ensuring respect for the instructions and rules established in the field of health, safety and the environment (in particular the LISI golden rules) o Immediately correcting, whenever possible, or reporting to his or her superiors and/or the HSE department, any malfunction or risky situation in the fields of health, safety and environmental protection o Implementing preventive actions to reduce the environmental footprint and control health and safety risks · Participate, upon request, in analyses (of risks, incidents) and HSE working groups related to his/her professional scope · Be familiar with the main health and safety risks and the main environmental impacts relating to the scope of his/her work · Be familiar with the site's HSE policy and objectives · To be able to make proposals for improving working conditions and limiting environmental impact