Quality Technician - 2nd Shift

Reports to:
Quality Engineering Manager

EDUCATION, BUSINESS EXPERIENCE AND PHYSICAL REQUIREMENTS
HS diploma and minimum 2 years relevant medical device/ISO 13485 experience or 2 yr degree.
Knowledge and experience with electronics manufacturing preferred
Good math and technical skills
Excellent computer skills including MS Office
Knowledge of quality systems including use of electronic quality management systems software preferred.
Knowledge of electrical and mechanical testing techniques.

REQUIRED COMPETENCIES
Leadership/Personal Conduct:
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.
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.
Communication
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.
 

DESCRIPTION OF RESPONSIBILITIES
The Quality Technician performs materials and product assessment testing in support of medical device development and manufacturing in compliance with GMP. The individual is responsible for receiving and in-process inspections, material release in support of medical device manufacturing.  The Quality Technician may be called upon for reviewing and approving job travelers (DHRs) prior to product release.
In addition, the 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.
Other duties may be assigned.

KEY RESULT AREAS
Development/Manufacturing Support:
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.
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.
Quality Systems:
Develop and write quality systems procedures as requested by supervisor.
Provides support during customer audits.
Supports supervisor in preparation of Management Review.