Quality Engineer I — Medical Devices & Process Quality

Agiliti; Kansas; On-site; USD 55,000 - 85,000; Full time

Benefits offered by this job

Health insurance

401K matching

Paid time off

Tuition reimbursement

Daily Pay program

Employee discounts

Wellness programs

Life Insurance Options

Short- and Long-Term Disability

Job summary

Agiliti is seeking a Quality Engineer I to apply quality engineering systems and practices across manufacturing and design centers in Kansas. You will collaborate with design, manufacturing, and supply chain teams to ensure product quality and regulatory compliance.

The role involves supporting quality decisions, using statistical methods, and helping validate materials, processes, and equipment. A BS in engineering and up to 5 years’ ISO manufacturing experience are preferred.

Qualifications

• Bachelor’s Degree in Engineering, Scientific, or Technical subject.
• 0–5 yrs. of relevant experience, preferably in an ISO regulated manufacturing environment.
• ISO13485 experience preferred, but not required.
• Metrology lab knowledge preferred, but not required.
• ISO14971 Risk Management knowledge preferred, but not required.
• IEC 60601-1 Safety standards knowledge preferred, but not required.
• APQP experience preferred, but not required.
• Use of statistical analysis software for SPC & CPk Analysis
• Tooling and fixturing development and qualification (FAI and Gage R&R)

Responsibilities

• Acts as a team member in supporting quality decisions and practices.
• Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Applies statistical methodologies for assessment and to resolve potential product and quality system issues.
• Participates in developing and maintaining testing plans, models and methods for raw materials, materials in process, and finished goods.
• Collaborates with Design, Manufacturing, and Supply Chain teams to select and monitor suppliers.
• Participates in the planning, execution, and maintenance of equipment validation activities.
• Participates in the planning, execution and maintenance of tooling verification and validations in conjunction with manufacturing and engineering teams.
• Participates in plant MRB to assist with investigations and disposition of product nonconformances.
• Develops and maintains process control plans for laser cutting equipment and robotic welders with manufacturing and engineering teams.
• Collaborates with manufacturing to develop in-process inspection plans.
• Assists with activities to support medical device manufacturing, such as Risk Management, Process FMEA, and Quality Control Plans.
• Plans, develops and executes verification and validation protocols with oversight.
• Leads advanced product quality planning activities and assists in preparing new product designs for certification testing.
• Participates in projects and cross functional teams. May lead small scale projects.

Skills

MS Office

Analytical skills

Technical writing

Communication

Presentation skills

Project management

Education

Bachelor's Degree in Engineering

Tools

SolidWorks

Autodesk

Job description

Agiliti is seeking a Quality Engineer I to apply quality engineering systems and practices across manufacturing and design centers in Kansas. You will collaborate with design, manufacturing, and supply chain teams to ensure product quality and regulatory compliance.

The role involves supporting quality decisions, using statistical methods, and helping validate materials, processes, and equipment. A BS in engineering and up to 5 years’ ISO manufacturing experience are preferred.