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 PSM
2.

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