Quality Engineer

Position Summary:
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).
Key Responsibilities:

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.

Validation:

Lead validation of new products and technology (IQ, OQ, PQ).
Act as QA lead for equipment validation.

Customer and Supplier Interface:

Collaborate with customers and suppliers on new product processes.
Lead customer complaints and supplier SCAR management.

Statistical Analysis:

Compile and analyze statistical data to assess process capabilities.
Conduct PFMEA, GR&R, and SPC studies.

Quality System Documentation:

Create and maintain quality system documentation, including quality plans, inspection and control plans, and work instructions.

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.

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.

Production Support:

Assist production in achieving APU objectives.
Generate quality KPIs for PSM2.

Audits:

Perform internal and external audits.

Secondary Responsibilities:
Backup Support:

Serve as backup for other QEs on customer or internal tasks as requested by the Director of Quality.

Continuous Improvement:

Identify and support continuous improvement opportunities.
Participate in LEAP workshops.

Training:

Contribute to employee training.

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.

Compensation and Benefits Overview
Starting Pay Range for this position is $80,000-$100,000/Annually.
Minimum pay rates offered will comply with applicable county or city regulations if they exceed the listed range. Actual pay rates are determined based on various factors, including but not limited to, local labor market conditions, years of relevant experience, education, professional certifications, foreign language proficiency, and other job-specific qualifications.
Employees and their families are eligible to participate in a comprehensive benefits package, including company-sponsored medical, dental, vision, flexible spending accounts (FSA), health savings accounts (HSA), voluntary benefits, supplemental life/AD&D insurance, and the company’s 401(k) plan. Additional benefits include access to an employee assistance program (EAP) for employees and household members, long-term disability coverage, and short-term disability for full-time employees.
Full-time and Part-time employees receive Paid Time Off (PTO) based on years of service, as well as paid holidays, personal holidays and MN Safe and Sick Time.