| 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
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
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