Senior Quality Engineer

Senior Quality Engineer Monticello, MN 55563 $95,000

• $125,000 a year
• Full-time $95,000
• $125,000 a year

•

Full-time 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 ves of our customers.

Pay:

$95,000.00

• $125,000.

00 per year

Benefits:

401(k) Dental insurance Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person