Specific Job Functions:
- Performs receiving, in-process, and final inspection of components, materials, sub-assemblies, finished goods, packaging and labeling, including, where applicable, visual, and dimensional inspections, and functional testing
- Reviews device history records for completeness and accuracy prior to releasing product to inventory
- Audits Quality Management System (QMS) documentation to ensure completeness and accuracy
- Assists with physical product movement to inventory locations and performs transactions in the inventory control system
- Identifies nonconforming products and processes, and generates nonconformance documentation
- Assists with implementation of calibration and preventive maintenance programs
- Assists with environmental monitoring and control
- Assists Engineering with validation, qualification, and engineering studies
- Assists with any additional QMS-related activities, as needed
Physical Requirements:
Office and Manufacturing/Lab Environment
- Light lifting (approximately 25 pounds)
- Ability to read gauges and instruments
- Good manual dexterity, fine motor skills
Minimum Qualifications, Education & Work Experience:
- High school degree or equivalent required
- Good computer skills in word processing, spreadsheets, and databases
- Strong scheduling and organizational skills
Preferred Qualifications, Education & Work Experience:
- Quality Assurance experience in medical device or other regulated industry
- Good understanding of GMP or ISO requirements
Job Type: Full-time
Pay: $20.00 - $30.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work setting:
- In-person
- Manufacturing facility
- Office
Work Location: In person