* Performs inspections using standardized methods
* Performs incoming, in-process and final inspection of components, documents, service parts and finished devices
* Collects/Gathers inspection results data into tracking systems
* Performs quality data analysis and presents key performance metrics to leadership monthly and quarterly
* Maintains calibration system and perform calibration duties, such as:
* Calibrating manufacturing and QA/QC equipment per schedule
* Coordinating with outside vendors for external calibrations and repairs
* Reviewing all calibration documentation for completeness and accuracy
* Maintains all quality records (Training, Drawings, Procedures, Work Instructions and Device History Records)
* Maintains plant training matrix, coordinating plant training on all quality topics
* Maintenance of audit checklists and production records to ensure they record verification of critical to quality attributes
* Leads weekly MRB meetings for nonconforming material
* Assists in investigations of customer complaints to determine root cause and completes investigation work-flow
* Strict compliance to Quality Systems standards.
* Complies with Good Documentation Practices.
* Adheres to all safety policies and contributes to the achievement of safety goals & objectives.
* Provides ideas and actively participates in the implementation of written suggestions for continuous improvement.
* Effectively utilizes time, energy and resources to meet delivery goals.
* Maintains housekeeping standards in accordance with 5 S principles.
* Complete all required training applicable to assigned position.
* Exhibit positivity, flexibility, creativity, and a willingness to take on new responsibilities as requested or required.
* High School graduate or equivalent.
* 2 - 3 years of previous experience in a quality related function within a manufacturing environment.
* Ability to calculate mathematical equations such as arithmetic, fractions, algebra, statistics, and geometry.
* Ability to define problems, collect data, establish facts, and draw valid conclusions. Demonstrated understanding of problem-solving techniques.
* Ability to read and understand blue prints, bill of material, drawings, specifications, and instructions.
* Ability to use basic measuring equipment.
* Strong computer skills with demonstrated computer competency with Microsoft Office Suite, ability to run reports, and analyze data.
* Demonstrated ability to work in a team environment.
* Demonstrated ability to work with minimal supervision.
* Effective verbal and written communication skills.
* Must have thorough understanding of Current Good Manufacturing Practice (CGMP) and ISO 13485.
Must have physical ability and manual dexterity necessary to perform the duties pertaining to job.