Job Description

Description

Do you have experience as a Quality Assurance Inspector? Are you looking for a new role as a Quality Assurance Inspector? Remington Medical, Inc., a growing medical device design and manufacturing company located in Alpharetta, GA, has an immediate opening for an experienced Quality Assurance Inspector.

Position Information

Position Title:

QA Associate

Department Name:

Quality/Regulatory

Pay Status:

Hourly

Department No.:

24

Department Head:

Director of Quality Assurance

Quality Assurance Associate Inspector

Job Details

Job Type

Full-time

Alpharetta, GA

1. Verification of all RMI and CM product documentation to ensure each lot meets all requirements for release.

2. Completion of accurate product and raw material inspection and testing in a timely manner.

3. Perform Environmental monitoring of ISO Class 8 Cleanrooms.

4. Assist with endotoxin testing for applicable products.

5. Assist with certain in-house equipment calibrations and preventive maintenance.

6. Assist with the resolution of raw material or product quality issues in a timely manner.

7. Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO, and FDA requirements.

Essential Physical Demands of the Position

The following demands are essential for adequate performance in this position.

Remington Medical will make reasonable accommodations for persons affected under the Americans with Disabilities Act.

Standing Time:

15 – 40%

Keyboard Time:

15 – 40%

Lifting:

5 – 25 lbs.

Essential Sensory Demands of the Position

The following demands are essential for adequate performance in this position.

Remington Medical will make reasonable accommodations for persons affected under the Americans with Disabilities Act.

Audible Sensory:

Normal Conversation

Visual Concentration:

Over 70%

Color Perception:

Essential*

* If inspections of color-coded electrical components or other color determinations are required.

Working Conditions

Vehicle Operations:

Work may require employee to operate an automobile, van or truck in connection with job requirements. Employee must agree to maintain a valid driver's license.

Work Hours:

Work may require extended work hours during peak periods.

Travel:

No travel required.

Other Duties

Job duties other than those specifically detailed in this job specification may be assigned from time to time if deemed necessary for the orderly conduct of business. Such assignments may become a permanent element of this position. Management at any time as deemed necessary may make changes to this job description. This document does not serve as a checklist for promotion criteria.

Requirements

Section 2 – Minimum Position Qualifications

Qualified Candidate Requirements Summary

1. High school / GED degree required
2. Associates degree in Technical School or equivalent work experience preferred
3. 3+ years related QA experience in the areas of inspection/test, auditing, or compliance in a medical device or FDA regulated industry preferred
4. Working knowledge of GMPs, GDPs, FDA QSRs, and ISO 13485 requirements
5. Ability to conduct sterilization and device history record audits
6. Intermediate or above level of proficiency with MS Office applications
7. Ability to utilize basic math skills – compute rate, ratio, and percent; draw and interpret bar graphs and charts; complete and document accurate counts of objects
8. Ability to solve practical problems and deal with a variety of variables in situations where limited standardization exists
9. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form, including part drawings, specification documents, work instructions, and test methods
10. Ability to use a variety of inspection and test equipment with accuracy and repeatability
11. Excellent written and verbal communication skills in English

Relevant Work Experience (in a related field)

Required Length of Service:

1-2 years

Desired Length of Service:

3-5 years

Other Experience Preferences:

Life Science Industries

Any Regulated Industry

Minimum Education Level

Education Level:

Required :

High School / GED

Preferred:

Technical School Associate's Degree (or equivalent degree)

Equivalent Work Experience

Remington Medical is an Equal Opportunity Employer.

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