Location: Eden Prairie, MN
CHF Solutions is an early stage company focused on commercializing the Aquadex FlexFlow® system. Our objective is to improve the quality of life for patients with heart failure and related conditions, such as fluid overload. We are seeking a Quality Technician for our Eden Prairie, MN location.
This position is responsible for assigned aspects of the Quality System to assure compliance with the Quality System Regulations (QSR), ISO, and other applicable requirements. This position will be expected to apply his/her knowledge of quality systems to the administration and/or support of the Quality System.
- Serve as Manufacturing floor support for questions, inspections, NCMR processing and other activities as assigned
- Own NCMR identification, initiation, quarantine, investigation, and product disposition
- Coordinate equipment calibration and preventive maintenance
- Perform component and product receiving, inspection, in-process inspections, and finished goods inspection, release, and distribution
- Assist with qualification/validation protocol development and execution
- Assist in maintaining accurate training records for all employees and presenting training material
- Assist with all Quality Systems investigations (NCMR, CAPA, SCAR, Complaint, etc)
- Assist in complaint product processing receipt, failure analysis, and disposal
- Assist in collecting and publishing Quality System Metrics
- Participate in internal, external, and supplier audits as needed
- Write and revise documents and process through change control system as required
- Assures all Quality System documentation and record keeping activities are carried out and completed in compliance with established procedures and work instructions
- May be assigned other duties as determined by management
- Minimum 2 years previous experience in regulated industry required with medical device experience preferred
- AA degree in a technical field or equivalent work experience strongly preferred
- Detail oriented/accurate record keeping skills
- Good communication/interpersonal skills
- Proficient in MS Excel, Word, Power Point
- Organized with the ability to prioritize multiple tasks
- Team oriented
How to Apply: If you are interested in applying for this position, email your cover letter and resume to firstname.lastname@example.org. Please indicate the position that you are applying for and the Requisition ID.
Requisition ID: 18-047
CHF Solutions, Inc. is an equal opportunity employer.
The above statements reflect the principal function and most significant duties of the job necessary for its evaluation in relation to other jobs in the organization, and shall not be construed as a detailed description of all the work requirements that may be inherent in the job.