Quality Assurance Specialist

2 weeks ago

Alpharetta, United States Remington Medical Inc Full time

Are you skilled in quality assurance processes? Remington Medical, Inc., a dynamic organization in the medical device sector, is seeking a dedicated Quality Assurance Associate.

Position Overview

Job Title: QA Associate

Department: Quality/Regulatory

Employment Type: Hourly

Department Number: 24

Reporting To: VP of Quality Assurance & Regulatory Affairs

Key Responsibilities

The following duties are essential for this role:

  1. Review and verify all product documentation to ensure compliance with release requirements.
  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 calibration and preventive maintenance of specific in-house equipment.
  6. Help resolve 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 and Sensory Requirements

This position requires the following physical and sensory capabilities:

Standing: 15 – 40%

Keyboard Use: 15 – 40%

Lifting Capacity: 5 – 25 lbs.

Auditory Skills: Normal conversation

Visual Focus: Over 70%

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

Work Environment

Vehicle Operation: May require operating a vehicle as part of job duties; a valid driver's license is necessary.

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

Travel: No travel is necessary for this position.

Additional Responsibilities

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



Qualifications

Candidate Requirements

  1. High school diploma or GED is required.
  2. Associate's degree from a technical school or equivalent experience is preferred.
  3. 3+ years of relevant QA experience in inspection, testing, auditing, or compliance within a medical device or FDA-regulated environment is preferred.
  4. Familiarity with GMPs, GDPs, FDA QSRs, and ISO 13485 standards.
  5. Ability to conduct audits of sterilization processes and device history records.
  6. Intermediate proficiency in MS Office applications.
  7. Basic math skills are necessary for calculations and data interpretation.
  8. Problem-solving skills to address various situations with limited standardization.
  9. Ability to interpret written, oral, and diagrammatic instructions, including specifications and test methods.
  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 related fields, particularly in life sciences or regulated industries.

Education Level

Required: High School / GED

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

Remington Medical is an Equal Opportunity Employer.



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