Quality Test Technician III

Enable Injections Inc.•Sharonville, OH

6d•Onsite

About The Position

QUALIFICATIONS Required: High School diploma or GED A minimum of four (4) years of previous industry experience with required, testing, and/or measurement experience Good working knowledge of product and manufacturing processes within the plant Attention to detail and experience with good documentation practices Preferred: Proficient in all aspects of Quality Control/Assurance procedures and possess a detailed knowledge of product components and their impact on assembly and use of the finished product Knowledgeable of ISO13485 Quality Standard Knowledge of FDA 21 CFR820 regulations Experience with testing and documentation in a regulated industry Skills & Competencies: Proficient at reading and writing English Ability to work with others (interpersonal skills) Ability to give and receive feedback Ability to train others Ability to solve problems and make informed decisions Ability to plan and organize job tasks Ability to set priorities and timelines Ability to communicate (both verbally and in writing) Ability to break down tasks into their parts Ability to understand drawings, specifications, and work instructions Ability to communicate clearly with all levels of personnel Proficient using SAP Proficient using Microsoft Office including Word, and Excel Proficient using knowledge of Product specifications Proficient using inspection methods and documentation Proficient using basic Engineering print understanding Ability to independently adapt behaviors to deal with non-routine components of the job Quickly adapts to a diverse array of changing needs, conditions, priorities, or opportunities Solid ability to achieve productivity goals and targets to meet department goals with little guidance Ability to follow defined procedures, proactively respond and problem solve Hands-on approach and mechanical aptitude Ability to stay focused on tasks, apply learned skills/training on the job, understand job responsibilities, organize, compare, interpret data, analyze problems, and troubleshoot solutions with guidance Work to acquire and develop new skills Strong ability to collaborate and maintain cooperative work relationships Foster teamwork, collaboration, and positively influencing others Consistently open and approachable when resolving sensitive issues Engage co-workers with the Enable Values in mind Strong ability to maintain a positive attitude and show empathy for others Display emotional tendencies that help support a positive work culture Time management skills, the ability to use your time effectively or productively at work Physical Requirements: Able to remain stationary for long periods of time Must be able to work standing for up to 2 hours Able to move about within the office Able to move up to 25 pounds with little or no trouble Able to perform repetitive manual tasks Ability to gown and complete tasks in a clean room Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc. Position requires being physically present on the premises during regular company hours or as approved by management

Requirements

High School diploma or GED
A minimum of four (4) years of previous industry experience with required, testing, and/or measurement experience
Good working knowledge of product and manufacturing processes within the plant
Attention to detail and experience with good documentation practices
Proficient at reading and writing English
Ability to work with others (interpersonal skills)
Ability to give and receive feedback
Ability to train others
Ability to solve problems and make informed decisions
Ability to plan and organize job tasks
Ability to set priorities and timelines
Ability to communicate (both verbally and in writing)
Ability to break down tasks into their parts
Ability to understand drawings, specifications, and work instructions
Ability to communicate clearly with all levels of personnel
Proficient using SAP
Proficient using Microsoft Office including Word, and Excel
Proficient using knowledge of Product specifications
Proficient using inspection methods and documentation
Proficient using basic Engineering print understanding
Ability to independently adapt behaviors to deal with non-routine components of the job
Quickly adapts to a diverse array of changing needs, conditions, priorities, or opportunities
Solid ability to achieve productivity goals and targets to meet department goals with little guidance
Ability to follow defined procedures, proactively respond and problem solve
Hands-on approach and mechanical aptitude
Ability to stay focused on tasks, apply learned skills/training on the job, understand job responsibilities, organize, compare, interpret data, analyze problems, and troubleshoot solutions with guidance
Work to acquire and develop new skills
Strong ability to collaborate and maintain cooperative work relationships
Foster teamwork, collaboration, and positively influencing others
Consistently open and approachable when resolving sensitive issues
Engage co-workers with the Enable Values in mind
Strong ability to maintain a positive attitude and show empathy for others
Display emotional tendencies that help support a positive work culture
Time management skills, the ability to use your time effectively or productively at work
Able to remain stationary for long periods of time
Must be able to work standing for up to 2 hours
Able to move about within the office
Able to move up to 25 pounds with little or no trouble
Able to perform repetitive manual tasks
Ability to gown and complete tasks in a clean room
Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
Position requires being physically present on the premises during regular company hours or as approved by management

Nice To Haves

Proficient in all aspects of Quality Control/Assurance procedures and possess a detailed knowledge of product components and their impact on assembly and use of the finished product
Knowledgeable of ISO13485 Quality Standard
Knowledge of FDA 21 CFR820 regulations
Experience with testing and documentation in a regulated industry

Responsibilities

Assist with Batch Disposition responsibilities for Materials, Components, and Sub-Assemblies
Ensures product safety, regulatory compliance, and compliance through proper management of quality documents and quality records
Execute finished product testing per defined procedures and work instructions
Produce high-quality records of results, with attention to detail and adherence to Enable Injections quality requirements
Collaborate with colleagues to diagnose and resolve unexpected issues which arise during routine operations
Support Manufacturing Operations through Operator compliance to Quality system, Quality Alerts, Training, In process Audit Inspections, Specialty Quality Inspections, Manufacturing record review, Inspection guidance, etc.
Support Quality Department with assisting in data collection for metric reporting, Quality improvement projects, special audits, and development of inspection methods
Support company corporate goals and objectives, infrastructure goals and objectives, manufacturing goals and objectives, and Quality Management System goals and objectives
Report “out of control” conditions and assist operations in analysis and reaction procedure
Support DHR document review for completeness and compliance
Maintain a clean, organized, and safe work environment
Take responsibility for own safety
Hold self-accountable to follow all safety policies & procedures
Support debrief accidents & implement solutions to eliminate root cause