Quality Control Associate

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 reputable medical device design and manufacturing organization, is currently looking for a qualified Quality Assurance Associate.

Position Details

Job Title: Quality Assurance Associate

Department: Quality/Regulatory

Employment Type: Hourly

Department Number: 24

Reporting To: VP of Quality Assurance & Regulatory Affairs

Key Responsibilities

  1. Review and verify all product documentation to ensure compliance with release criteria.
  2. Conduct thorough inspections and testing of products and raw materials promptly.
  3. Perform environmental monitoring within 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 any quality issues related to raw materials or products efficiently.
  7. Ensure adherence to Quality System SOPs, work instructions, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO standards, and FDA regulations.

Physical Requirements

This position requires certain physical capabilities for effective performance. Remington Medical is committed to providing reasonable accommodations as per the Americans with Disabilities Act.

Standing: 15 – 40%

Keyboard Usage: 15 – 40%

Lifting Capacity: 5 – 25 lbs.

Sensory Requirements

Essential sensory abilities are necessary for this role. Remington Medical will accommodate individuals affected under the Americans with Disabilities Act.

Auditory: Normal conversation

Visual Focus: Over 70%

Color Recognition: Required for tasks involving color-coded components.

Working Conditions

Vehicle Operation: The role may involve operating a vehicle as part of job duties, requiring a valid driver's license.

Work Hours: Extended hours may be necessary during peak times.

Travel: No travel is required for this position.

Additional Responsibilities

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

Qualifications

Required:

  1. High school diploma or GED.
  2. Preferred: Associate's degree from a technical school or equivalent experience.
  3. 3+ years of relevant QA experience in inspection, testing, auditing, or compliance within a medical device or FDA-regulated environment.
  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 for computations and data interpretation.
  8. Problem-solving skills to address various situations with limited standardization.
  9. Ability to interpret instructions in various formats including written, oral, and diagrams.
  10. Experience using inspection and testing equipment accurately.
  11. Strong written and verbal communication skills in English.

Experience Requirements

Minimum Experience: 1-2 years in a related field.

Preferred Experience: 3-5 years in life sciences or regulated industries.

Education Level

Required: High School / GED

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

Equal Opportunity Employer

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