Quality Engineer I

Agiliti•Hays, KS

1d•Onsite

About The Position

The Quality Engineer I will utilize and maintain quality engineering systems and practices in collaboration with Agiliti manufacturing and design centers that meet and exceed internal, customer, and regulatory requirements.

Requirements

Bachelor’s Degree (BS) in Engineering, Scientific, or Technical related subject required.
0-5 yrs. of relevant experience, preferably in an ISO regulated manufacturing environment.
Use of statistical analysis software for SPC & CPk Analysis
Tooling and fixturing development and qualification (FAI and Gage R&R)
Proficient computer skills in MS Office Suite, including MS Project and Visio.
Strong analytical skills and attention to detail
Strong technical writing skills and effective communication skills
Strong presentation, facilitation, and project management skills

Nice To Haves

ISO13485 experience preferred, but not required.
Working knowledge and experience in metrology lab preferred, but not required.
Working knowledge of ISO14971 Risk Management preferred, but not required.
Working knowledge of IEC 60601-1 Safety standards preferred, but not required.
Advanced Product Quality Planning experience (APQP) preferred, but not required.
Working knowledge of CAD software preferred (i.e., SolidWorks, Autodesk, etc.)

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. (IQ, OP and PQ)
Participates in the planning, execution and maintenance of tooling verification and validations in conjunction with manufacturing and engineering teams.
Participates in plant Material Review Boards (MRB) to assist with investigations and disposition of product nonconformances.
Develops and maintains process control plans for laser cutting equipment and robotic welders collaboratively 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.