A medical device manufacturing company is looking to hire a Quality Technician onsite in Burnsville. This person will be responsible for supporting product manufacturing through duties of receiving Inspection, facilitating calibration & preventative maintenance, DHR review, and manufacturing quality support. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies
Responsibilities
- Performs receiving and inspection activities for components, subassemblies, labeling, and finished products to support production.
- Performs First Article Inspections (FAIs) by utilizing tools such as calipers, micrometers, gauges, and tensile testers.
- Facilitates calibration activities through a 3rd party calibration vender.
- Facilitates/manages preventative maintenance activities through the Operations department.
- Performs Design History Record (DHR) reviews and manages documentation in electronic Quality Management System (QMS).
- Performs small change orders for quick process improvements or QMS improvements.
- Interfaces with Operators on manufacturing line to resolve minor issues such as equipment errors or documentation errors.
- Executes Test Method Validations (TMVs), material reworks through nonconformances, or other released procedures.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
Qualifications
- Two-year degree or equivalent experience in quality or manufacturing environment or relevant industry.
- Minimum of 3 years experience in quality and manufacturing environment, including good documentation practice skills to maintain neat and accurate records and files.
- Knowledge and experience with inspection concepts, general measuring tools and test equipment, and maintenance and calibration programs.
- Knowledge of ISO 13485 requirements preferred.
- Experience with Microsoft Office: Word, Excel, PowerPoint.
- Must be able to read, write and speak fluent English.
Salary of $60 - 66K annually.