Quality Assurance Technician I

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 fac...