Quality Engineer II

Agiliti•Kansas - Home based, KS

3d•$65,269 - $169,743•Hybrid

About The Position

The Quality Engineer II 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. Location for this role is flexible / can work remote when not traveling. Must be willing to travel to Design Center located in Milwaukee, WI and Manufacturing Sites in Kansas and California to participate in Design Reviews and other specific Design and Development Activities.

Requirements

Bachelor’s Degree (BS) in Engineering, Scientific, or Technical related subject required.
3-7 yrs. of relevant experience, preferably in Design and Development in an ISO13485, FDA 21CFR820 and MDSAP regulated environment, mainly for the Design Controls process and requirements.
Previous working experience in a Design Quality Assurance role for medical device equipment is required.
Minimum 3 years of working experience with Corrective and Preventive Actions at the Design and Development phase of a product lifecycle.
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 and FDA 21CFR820 highly desired.
Working knowledge and experience with metrology labs preferred and GD&T.
Experience with medical device ISO14971 Risk Management.
Working knowledge of IEC 60601-1 Safety standards preferred, but not required.
Use of statistical analysis software for SPC & CPk Analysis
Tooling and fixturing development and qualification (FAI and Gage R&R)
Working knowledge of CAD software preferred (i.e., SolidWorks, Autodesk, etc.)
High level knowledge of DFSS concepts and tools preferred, but not required.

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.
Develops and maintains or supports the development of testing plans, models and methods for raw materials, materials in process, and finished goods.
Collaborates with Design, Manufacturing, and Supply Chain teams ensuring adequacy of product specifications to select and monitor suppliers.
Coordinates planning and execution of first article inspections and approvals.
Coordinate planning, execution and maintenance of tooling verification and validations in conjunction with manufacturing and engineering teams.
Leads activities to support medical device manufacturing, such as Risk Management, Process FMEA, and Quality Control Plans.
Plans, develops, and oversees execution of Design verification and validation protocols.
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 mid-scale projects.