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Quality Assurance Evaluator
2 months ago
Are you experienced in quality assurance within the medical device sector? Remington Medical, Inc., a dynamic company in the medical device design and manufacturing industry, is seeking a qualified Quality Assurance Associate.
Position Overview
Job Title: Quality Assurance Associate
Department: Quality/Regulatory
Employment Type: Hourly
Department Number: 24
Reporting To: VP of Quality Assurance & Regulatory Affairs
Key Responsibilities
- Review and verify all product documentation to ensure compliance with release requirements.
- Conduct thorough inspections and testing of products and raw materials efficiently.
- Perform environmental monitoring in ISO Class 8 Cleanrooms.
- Assist in endotoxin testing for relevant products.
- Support in-house equipment calibrations and preventive maintenance.
- Help resolve quality issues related to raw materials or products promptly.
- Ensure adherence to Quality System SOPs, work instructions, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO standards, and FDA regulations.
Physical Requirements
The following physical demands are essential for this role:
Standing: 15 – 40%
Keyboard Usage: 15 – 40%
Lifting Capacity: 5 – 25 lbs.
Sensory Requirements
Auditory: Normal conversation
Visual Concentration: Over 70%
Color Discrimination: Essential for tasks involving color-coded components.
Work Environment
Vehicle Operation: May require operation of a vehicle for job-related tasks; 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 for the effective operation of the business. Management reserves the right to modify this job description as necessary.
Qualifications
Candidate 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 related to sterilization and device history records.
- Intermediate proficiency in MS Office applications.
- Basic math skills for calculations and data interpretation.
- Problem-solving skills to address 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.
Preferred Industries: Life Sciences, 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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