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