Job Description
About Us:
Pramand, LLC, a developer of surgical sealants, is growing! We are seeking an experienced Quality Assurance Technician to support our expanding product offerings. This important role supports manufacturing operations by performing critical inspections of incoming and in-process materials and executing lot release testing. The ideal candidate will have a solid base of experience in medical device manufacturing and firsthand understanding of Quality Assurance methodology in a regulated environment.
Position Summary:
The Quality Assurance Technician maintains quality standards for medical devices and other products by performing quality control inspections and testing. Documents and communicates inspection results.
Principal Duties and Responsibilities:
- Perform inspections across all stages of production
- Perform inspections of raw materials and incoming inventory
- Interact with manufacturing department to ensure inspections are completed in a timely manner
- Prepare and maintain test data for review
- Generate non-conforming material reports as required
- Communicate quality or compliance concerns with urgency
- Maintain quality testing and trending program
- Assist in quality monitoring and measurement system
- Perform Quality Assurance testing in support of product development as needed
- Assist in maintenance of calibration system and equipment
- Performs additional quality duties as assigned
- Identify areas for quality control improvement and implement new methods accordingly
- Other duties may be assigned
Qualification Requirements:
Education:
High school diploma or relevant work experience
Experience:
0+ years of inspection and/or production experience or experience in a regulatory and/or controlled environment (i.e. medical device, pharmaceutical, biomedical industry or diagnostic laboratory setting)
Knowledge/Skill:
- Excellent organizational skills and attention to detail
- Strong communication skills
- Computer literacy, proficiency in Microsoft office
- Familiarity with quality measuring instruments i.e. calipers, pipettes, balances and general laboratory equipment
- Experience working in a clean room preferred
- Demonstrated ability to work independently with minimal supervision
- Demonstrated ability to analyze and interpret information
Working Conditions:
Physical demands required to perform testing/inspections:
- Employee may be required to lift 25 lbs.
- Perform visual inspections