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Quality Control Specialist

2 months 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 organization in the medical device sector, is currently looking for a qualified Quality Assurance Associate.

Key Responsibilities

  1. Ensure thorough verification of all product documentation to confirm compliance with release standards.
  2. Conduct precise inspections and testing of products and raw materials within established timelines.
  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 activities.
  6. Address and resolve quality issues related to raw materials or products promptly.
  7. Maintain adherence to Quality System SOPs, work instructions, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO standards, and FDA regulations.

Physical and Sensory Requirements

This position requires the following physical and sensory capabilities:

  • Standing Time: 15 – 40%
  • Keyboard Time: 15 – 40%
  • Lifting: 5 – 25 lbs.

Working Conditions

Employees may need to operate vehicles as part of their job responsibilities and must maintain a valid driver's license. Extended work hours may be required during peak periods, but no travel is necessary.

Qualifications

  1. High school diploma or GED is required.
  2. Preferred: Associate's degree from a Technical School or equivalent experience.
  3. Minimum of 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 documentation.
  8. Problem-solving skills to address various situations with limited standardization.
  9. Ability to interpret diverse instructions, including written, oral, and diagrammatic forms.
  10. Proficiency in using various inspection and testing equipment accurately.
  11. Strong written and verbal communication skills in English.

Experience Requirements

Relevant work experience in related fields is preferred, with a desired length of service between 3 to 5 years.

Education Requirements

Required: High School / GED

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

Equal Opportunity Employer