Quality Control Specialist
2 weeks ago
Are you an experienced Quality Assurance Inspector seeking a new opportunity? Remington Medical, Inc., a dynamic organization in the medical device sector, is currently looking for a qualified Quality Assurance Inspector.
Position Details
Job Title: QA Associate
Department: Quality/Regulatory
Employment Type: Hourly
Department Number: 24
Supervisor: VP of Quality Assurance & Regulatory Affairs
Key Responsibilities
- Ensure all product documentation from RMI and CM is verified for compliance prior to release.
- Conduct thorough inspections and testing of products and raw materials promptly.
- Perform environmental monitoring within ISO Class 8 Cleanrooms.
- Assist in endotoxin testing for relevant products.
- Support calibration and preventive maintenance of specific in-house equipment.
- Help resolve quality issues related to raw materials or products efficiently.
- Comply with Quality System SOPs, work instructions, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO standards, and FDA regulations.
Physical Requirements
To perform effectively in this role, the following physical demands are essential:
Standing: 15 – 40%
Keyboard Usage: 15 – 40%
Lifting Capacity: 5 – 25 lbs.
Sensory Requirements
The following sensory abilities are necessary for this position:
Auditory: Normal conversation levels
Visual Focus: Over 70%
Color Discrimination: Essential for tasks involving color-coded components.
Work Environment
Vehicle Operation: The role may require operating a vehicle as part of job responsibilities. A valid driver's license is necessary.
Work Hours: Extended hours may be required during busy periods.
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
Minimum Requirements:
- High school diploma or GED is required.
- Associate's degree from a technical school or equivalent experience is preferred.
- 3+ years of relevant QA experience in inspection, testing, auditing, or compliance within a medical device or FDA-regulated environment is preferred.
- Familiarity with GMPs, GDPs, FDA QSRs, and ISO 13485 standards.
- Ability to conduct audits of sterilization processes and device history records.
- Intermediate proficiency in MS Office applications.
- Basic math skills for computations and data interpretation.
- Problem-solving skills to handle various situations with limited standardization.
- Ability to interpret diverse instructions in various formats.
- Proficiency in using inspection and testing equipment accurately.
- Strong written and verbal communication skills in English.
Experience Requirements
Required Experience: 1-2 years
Preferred Experience: 3-5 years in relevant fields.
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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