Quality Engineer

LISI•Big Lake, MN

59d•Onsite

About The Position

The Quality Engineer is responsible for developing new processes/products, validating new equipment and technology, assisting production with continuous improvement on the shop floor, managing customer complaints, and handling CAPA/NCR activities. This role also involves leading change requests with customers and ensuring compliance with ISO 13485, FDA, and other applicable standards. The Quality Engineer collaborates closely with QA Technicians and Quality Inspectors (QAR). 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
Lead validation of new products and technology (IQ, OQ, PQ).
Act as QA lead for equipment validation.
Collaborate with customers and suppliers on new product processes.
Lead customer complaints and supplier SCAR management.
Compile and analyze statistical data to assess process capabilities.
Conduct PFMEA, GR&R, and SPC studies.
Create and maintain quality system documentation, including quality plans, inspection and control plans, and work instructions.
Manage NCR, CAPA, and customer complaints from creation to closure.
Use problem-solving tools and work as part of a cross-functional team.
Lead changes in production, ensuring compliance with customer agreements, ISO standards, and internal requirements.
Prepare, submit, and follow change requests (SCR) with customers.
Assist production in achieving APU objectives.
Generate quality KPIs for PSM2.
Perform internal and external audits.
Serve as backup for other QEs on customer or internal tasks as requested by the Director of Quality.
Identify and support continuous improvement opportunities.
Participate in LEAP workshops.
Contribute to employee training.
Perform other duties as assigned.