* 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.