Senior Quality Technician

Elucent Medical•Eden Prairie, MN

About The Position

Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes. Job Summary: The Sr. Quality Technician performs material and product assessment testing in support of medical device development and manufacturing in compliance with GMP. This role has the knowledge and experience to provide assistance in the development of other technicians They will be assigned complaint, RMA tasks and perform engineering related requests as assigned. The individual is also responsible for, receiving and in-process inspections, material release in support of medical device manufacturing. The Sr. Quality Technician will be responsible for reviewing and approving job travelers (DHRs) prior to product release. In addition, the Sr. Quality Technician will support administration of quality systems within the electronic quality management system, as assigned. In this role, the position works cross functionally with process stakeholders to ensure quality system processes are documented appropriately and are completed within the expected timeframes. Supervisory Responsibilities: None.

Requirements

HS diploma and minimum 2 years relevant medical device/ISO 13485 experience or 2 yr degree.
Knowledge and experience with electronics manufacturing preferred.
Knowledge of quality systems including use of electronic quality management systems software preferred.
Knowledge of electrical and mechanical testing techniques.
Good math and technical skills.
Excellent computer skills including MS Office.
Maintains positive attitude when working with peers, customers or suppliers.
Comfortable working in a self-directed team environment and giving or asking for instructions.
Demonstrate an understanding of the medical industry.
Provide training to peers on technician level skills.
Works effectively on cross functional teams to establish appropriate processes pertaining to quality.
Individual must have a hands-on approach.
Strong organizational and time management skills.
Excellent written and oral communication skills.
Positive and cooperative communications and collaboration with all levels of employees, customers, contractors and suppliers.
Ability to review, analyze, summarize and interpret data; draw conclusions and make appropriate recommendations and decisions.
Must be able to lift up to 40 pounds at times.

Responsibilities

Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions.
Responsible for receiving inspection activities including, but not limited to inspection and gathering all defined requirements and documentation to release parts/components.
Responsible for performing in-process and final component, sub-assembly and product inspection.
Document non-conformance reports once parts fail specification or requirements.
Performs and/or supports troubleshooting, investigations and problem solving of issues and non-conformances.
Complaint related tasks.
RMA tasks.
Assures quality systems documentation and record keeping activities are carried out and completed in compliance with established procedures and work instructions.
Demonstrates safe work habits, maintains clean and safe work area.
Completes all other duties as assigned by supervisor.
Develop and write quality systems procedures as requested by supervisor.
Provides support during customer audits.
Supports supervisor in preparation of Management Review.