We are seeking a detail-oriented Quality Control Inspector to join our team. As a Quality Control Inspector you will be responsible for ensuring the quality and safety of our products. The ideal candidate will have experience with quality control systems including FDA regulations and ISO Standards. Responsibilities: - Perform inspections of incoming in process and finished products for correct identification traceability and conformance to approved specifications.
- Performs visual and functional in-process and final inspection of devices and/or labels.
- Determine acceptability of raw materials components and subassemblies according to standards and internal requirements.
- Accept or reject parts based on outcomes of the inspections. Generate nonconforming material reports as needed.
- Document archive and maintain all inspection records device history records and all other quality documents.
- Perform other related quality functions as required by management.
Qualifications: - Minimum 2 years of quality assurance experience with in-process and final inspection exposure in a medical device manufacturing environment required.
- Demonstrates basic knowledge of Quality Management System and current Good Manufacturing Practices (cGMP).
- Demonstrates strong verbal written and interpersonal communication skills.
- Expertise in using precision measurement instruments such as calipers micrometers optical comparator height gauges pin gauges and more.
- Strong mathematics skills.
- Mechanical aptitude. Excellent ability to read engineering drawings and specifications.
- Demonstrate proficiency in both independent work and collaborative teamwork.
- Basic computer skills which include the use of Microsoft WORD and EXCEL.
- Preferred: Knowledge of Food and Drug Administration (FDA) and Hands-on manufacturing experience or medical device manufacturing.
Physical Requirements: - While performing the job duties the employee is required to regularly sit stand walk lift and move 25 pounds without assistance. They will need to reach with their hands and arms and be able to climb balance stoop kneel crouch and crawl. Fine hand motor skills are required to handle the product. This position will need to have specific vision abilities such as close vision distance vision peripheral vision depth perception and ability to adjust focus when working with product in the warehouse. The individual will need to be able to communicate hear and be aware of their surroundings to ensure the safety of the team.
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