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Quality Assurance Analyst
2 months ago
Are you an experienced Quality Assurance professional? Remington Medical, Inc., a prominent player in the medical device design and manufacturing sector, is seeking a skilled Quality Assurance Associate.
Position Overview
Job Title: QA Associate
Department: Quality/Regulatory
Employment Type: Hourly
Department Number: 24
Supervisor: VP of Quality Assurance & Regulatory Affairs
Key Responsibilities
- Review and verify all product documentation to confirm compliance with release requirements.
- Conduct thorough inspections and testing of products and raw materials promptly.
- Monitor environmental conditions in ISO Class 8 Cleanrooms.
- Assist in endotoxin testing for relevant products.
- Support in-house equipment calibrations and preventive maintenance activities.
- Help resolve quality issues related to raw materials or products efficiently.
- Ensure adherence to Quality System SOPs, work instructions, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO standards, and FDA regulations.
Physical Demands
This position requires certain physical capabilities, and reasonable accommodations will be made for individuals with disabilities as per the Americans with Disabilities Act.
Standing Requirement: 15 – 40%
Keyboard Usage: 15 – 40%
Lifting Capacity: 5 – 25 lbs.
Sensory Requirements
Essential sensory capabilities are necessary for this role, with accommodations available as needed.
Auditory Requirement: Normal conversation
Visual Focus: Over 70%
Color Discrimination: Necessary for tasks involving color-coded components.
Work Environment
Vehicle Operation: May require driving for job-related tasks; 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 support business operations, and 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 navigate varied situations with limited standardization.
- Ability to interpret various forms of instructions, including written, oral, and diagrammatic.
- Proficiency in using inspection and testing equipment accurately.
- Strong written and verbal communication skills in English.
Experience
Required Experience: 1-2 years
Preferred Experience: 3-5 years
Relevant Industry Experience: Life Sciences or any regulated industry.
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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