Quality Control Specialist

2 weeks ago

Alpharetta, United States Remington Medical Inc Full time
Position Overview

Are you an experienced Quality Assurance professional seeking a new opportunity? Remington Medical, Inc., a dynamic company in the medical device sector, is currently looking for a skilled Quality Assurance Associate.

Position Details

Job Title: QA Associate

Department: Quality/Regulatory

Employment Type: Hourly

Department Number: 24

Supervisor: VP of Quality Assurance & Regulatory Affairs

Key Responsibilities

Primary Duties

  1. Review and verify all product documentation to confirm compliance with release standards.
  2. Conduct thorough inspections and testing of products and raw materials efficiently.
  3. Perform environmental monitoring in ISO Class 8 Cleanrooms.
  4. Assist in endotoxin testing for relevant products.
  5. Support in-house equipment calibrations and preventive maintenance tasks.
  6. Help resolve quality issues related to raw materials or products promptly.
  7. Ensure adherence to Quality System SOPs, work instructions, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO, and FDA regulations.

Physical Requirements

The following physical demands are essential for successful performance in this role. Remington Medical will provide reasonable accommodations for individuals under the Americans with Disabilities Act.

Standing Duration: 15 – 40%

Keyboard Usage: 15 – 40%

Weight Handling: 5 – 25 lbs.

Sensory Requirements

The following sensory demands are crucial for effective job performance. Remington Medical will accommodate individuals as per the Americans with Disabilities Act.

Auditory Skills: Normal conversation

Visual Focus: Over 70%

Color Discrimination: Essential for specific inspections.

Work Environment

Vehicle Operation: Employees may need to operate vehicles as part of job responsibilities and must maintain a valid driver's license.

Work Hours: Extended hours may be required during busy periods.

Travel Requirements: No travel is necessary.

Additional Responsibilities

Other duties may be assigned as necessary for the effective operation of the business. Management reserves the right to modify this job description as needed.

Qualifications

Candidate Requirements

  1. High school diploma or GED required.
  2. Associate's degree from a technical school or equivalent experience preferred.
  3. Minimum of 3 years of relevant QA experience in inspection, testing, auditing, or compliance within a medical device or FDA-regulated environment preferred.
  4. Familiarity with GMPs, GDPs, FDA QSRs, and ISO 13485 standards.
  5. Ability to conduct audits related to sterilization and device history records.
  6. Intermediate proficiency in MS Office applications.
  7. Basic math skills required for calculations and data interpretation.
  8. Problem-solving skills to manage various situations with limited standardization.
  9. Ability to understand and interpret various forms of instructions, including written, oral, and diagrammatic.
  10. Experience using various inspection and testing equipment accurately.
  11. Strong written and verbal communication skills in English.

Experience Requirements

Required Experience: 1-2 years

Preferred Experience: 3-5 years in relevant fields.

Education Requirements

Required: High School / GED

Preferred: Technical School Associate's Degree or equivalent experience.

Remington Medical is an Equal Opportunity Employer.

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