Quality Engineer I: Medical Device QA & Process Validation

Agiliti Health, Inc.; Hays (KS); On-site; USD 60,000 - 84,000; Full time

Benefits offered by this job

Health insurance

401K with employer match

Paid time off

Tuition reimbursement

Daily Pay program

Wellness programs

Job summary

Agiliti Health, Inc. is hiring a Quality Engineer I to support quality systems across manufacturing and design centers, ensuring products meet regulatory standards and customer expectations.

You will work with design, manufacturing, and supply chain to monitor suppliers and drive quality decisions. The role involves developing and maintaining testing plans, executing equipment validation (IQ, OQ, PQ), and contributing to MRB investigations, process controls for laser and robotic welders, and

Qualifications

• Bachelor's degree in engineering, scientific, or technical field.
• 0–5 years of relevant experience in ISO-regulated manufacturing.
• ISO13485 experience preferred, but not required.
• Metrology lab knowledge preferred, but not required.
• APQP experience preferred, but not required.
• SPC & CPk analysis experience beneficial.

Responsibilities

• Acts as a team member in supporting quality decisions and practices.
• Applies systematic problem-solving methodologies to identify and resolve quality issues.
• Applies statistical methodologies for assessment and to resolve quality issues.
• Develops and maintains testing plans for raw materials, in-process materials and finished goods.
• Collaborates with Design, Manufacturing, and Supply Chain teams to monitor suppliers.
• Plans, executes and maintains equipment validation activities (IQ, OQ, PQ).
• Plans and maintains tooling verification and validations with manufacturing and engineering teams.
• Participates in MRB investigations and dispositions of nonconforming products.
• Develops process control plans for laser cutting equipment and robotic welders.
• Collaborates with manufacturing to develop in-process inspection plans.
• Supports Risk Management, FMEA, and Quality Control Plans.
• Leads verification/validation protocols and assists in new product certification testing.
• Participates in projects and cross-functional teams; may lead small projects.

Skills

MS Office Suite

MS Project

Visio

Analytical skills

Technical writing

Communication

Project management

Presentation skills

Education

Bachelor's Degree in Engineering, Scientific, or Technical related subject

Tools

SolidWorks

Autodesk

Job description

Agiliti Health, Inc. is hiring a Quality Engineer I to support quality systems across manufacturing and design centers, ensuring products meet regulatory standards and customer expectations.

You will work with design, manufacturing, and supply chain to monitor suppliers and drive quality decisions. The role involves developing and maintaining testing plans, executing equipment validation (IQ, OQ, PQ), and contributing to MRB investigations, process controls for laser and robotic welders, and