What are the responsibilities and job description for the Medical Device Quality Inspector position at Kellton?
Job Title: Medical Device Quality Inspector
Location: Madison, WI (Onsite)
Pay Rate: $30/hr (W2)
Job Summary
The Medical Device Quality Inspector is responsible for ensuring that materials, processes, and conditions related to the daily manufacturing, processing, and packaging of medical devices meet cGMP standards and comply with internal quality procedures and regulatory standards. This position plays a critical role in ensuring product quality and integrity in a regulated environment.
Essential Functions
Education & Experience:
Location: Madison, WI (Onsite)
Pay Rate: $30/hr (W2)
Job Summary
The Medical Device Quality Inspector is responsible for ensuring that materials, processes, and conditions related to the daily manufacturing, processing, and packaging of medical devices meet cGMP standards and comply with internal quality procedures and regulatory standards. This position plays a critical role in ensuring product quality and integrity in a regulated environment.
Essential Functions
- Perform one of the following Quality department functions:
- Inspect raw materials to ensure they meet production requirements.
- Conduct in-process inspections of products and manufacturing processes.
- Review final documentation and inspect packaging for medical devices, subassemblies, and kits.
- Assist in documentation control activities within the manufacturing facility.
- Complete activity documentation and attach appropriate quality status labeling.
- Ensure proper storage and secure handling of products and labels.
- Support the Quality team by occasionally conducting nonconformance investigations and assisting with preventive actions.
- Perform quality reviews for quarantine releases on specific non-reportable, non-complaint materials.
Education & Experience:
- High School diploma or equivalent required.
- Minimum 1 year of experience in a regulated work environment preferred.
- Familiarity with FDA Quality System Regulations and ISO 13485 standards for medical device manufacturing.
- Self-motivated and able to work independently.
- Strong attention to detail.
- Proficient in using computer-based systems daily.
- Strong teamwork and collaboration skills.
- Effective verbal and written communication abilities.
- Reports to the Quality Control Manager.
- Interfaces primarily with manufacturing, engineering, and quality departments to assess nonconforming products and support supplier quality issues.
- Work is performed in a controlled environment within a medical device manufacturing facility.
- Adherence to safety and hygiene protocols is required.
Salary : $30