Quality Engineer I

Quality Engineer I

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.

Primary Duties And 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.

Experience

• 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.
• 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.
• Use of statistical analysis software for SPC & CPk Analysis
• Tooling and fixturing development and qualification (FAI and Gage R&R)

Skills & Abilities

• Proficient computer skills in MS Office Suite, including MS Project and Visio.
• Working knowledge of CAD software preferred (i.e., SolidWorks, Autodesk, etc.)
• Strong analytical skills and attention to detail
• Strong technical writing skills and effective communication skills
• Strong presentation, facilitation, and project management skills

Primary Job Location:

Hays KS Branch

Additional Locations (if applicable):

Ellis KS Branch

Location City:

Hays

Location State:

Kansas