Quality Technician

A medical device client is looking to hire a Quality Technician for their night shift. This person will work Monday through Thursday, 3:30 PM to 1:30 AM and will be responsible for assisting engineers in developing and maintaining quality engineering methodologies. We are looking for someone who can also provide quality technical support within new product development, manufacturing, and quality systems.

Day To Day

• Complies with company, quality and safety standards, policies, and procedures.
• Under Quality Engineer oversight, assist with qualification and validation.
• Compile and analyze statistical data to assess process capabilities and control processes.
• Develop inspection test methods and draft inspection procedures with QE oversight.
• Handle Calibration Management including new and current equipment that requires calibration, calibration supplier management and out of tolerance reporting as required.
• Handle Environmental Monitoring Management including collecting samples, testing, entering, and trending results and out of tolerance reporting as required.
• Support the nonconforming material reporting process including verifying nonconformance descriptions, evaluating to determine root cause of the nonconformance and proposing final disposition of nonconforming product.
• Review and approve inspection and device history records as required.
• Support CAPA process by assisting in the investigation and implementation of corrective action.
• Identify areas of improvement and participate in continuous improvement projects.
• Perform Gemba walks and participate in 5S activities.

Must Haves:

• High School diploma.
• 1 year of experience in manufacturing environment, ideally medical device
• Knowledge of medical device regulations such as 21CFR820 and ISO 13485.
• Working knowledge of basic inspection processes and measurement practices.
• Must be able to read, write and speak fluid English.
• Ability to read and interpret assembly drawings and specifications.
• High proficiency in use of computer systems using standard business software such as Outlook, Word, PowerPoint, Excel, MRP/ERP systems.

This position is onsite and pays $24 an hour while on contract