Summary

The Quality Assurance Technician I is essential to the daily workload and long-term strategy of the Quality department. This position will incorporate all basic receiving quality assurance (RQA) skills and job functions as well as advanced functions including quality checks, administrative duties, testing and load release including ERP transactions, as well as, providing backup to document control system including but not limited to device master records, device history records, design history files, change notices, standard operating procedures, and numerous other Quality records. This position will act as the technical expert for RQA activities and will report to the Lead Quality Engineer.

Primary Responsibilities include the following. (Other duties may be assigned.)

1. Perform receiving and final inspections for Production.
2. Perform inspections for First Article/PPAP and prototypes.
3. Refer to drawings, specifications, procedures, work instructions, checklists, and technical documents when performing inspections.
4. Perform visual, dimensional, and physical inspections and testing for raw materials, purchased parts, and contract sterilizer as needed.
5. Document inspection results and summarize within DHR in compliance with Good Documentation Practices (GDP).
6. Update and maintain product status within the ERP system.
7. Maintain quality files including device history and sterilization records.
8. Manage and maintain customer returns.
9. Adhere to all Standard Operating Procedures while practicing safe work habits.

Job Specifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or

ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Minimum Qualifications

High School Diploma or General Education Degree (GED); and one to two years related experience and/or training; or equivalent combination of education and experience.

Must be able to use measuring equipment such as calipers, pin gauges, micrometers, scales, and optical comparator

Preferred Qualifications

1. Ability to operate power lift equipment including a fork truck.
2. Ability to communicate ideas in verbal and written format with employees in other departments as well as outside vendors and truck drivers.
3. Ability to understand and apply verbal and/or written instructions.
4. Ability to operate computer and computer applications including spreadsheets, databases, and work processing software. Experience with Microsoft Office.
5. Ability to add, subtract, multiply, and divide in all units of measure, using whole number, common fractions, and decimals. Ability to compute rate, ratio, and percent.
6. Regular attendance is required for the ability complete all work.
7. Requires face-to-face interaction with team members, peers and management to complete all work and provide support.
8. Ability to work more than 40 hours per week (overtime) if needed based on business demand.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to stand: walk; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must regularly lift and /or exert force to move up to 50 pounds, and occasionally lift and/or exert force to move up to 100 pounds via buddy lift. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and ability to adjust focus. Additionally, while performing the duties of this job, the employee is regularly required to use hands for computer operation and document filing.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; toxic or caustic chemicals and risk of electrical shock. The noise level in the work environment is usually moderate.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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