Quality Assurance Technician

Haemonetics • Clinton, PA

391d

About The Position

The Quality Assurance Technician plays a crucial role in ensuring product quality and compliance within the medical device manufacturing environment. This position involves various responsibilities, including documentation of inspection processes, management of calibration programs, and auditing product records to ensure adherence to quality standards. The technician will also engage in specialized testing and collaborate with manufacturing teams to implement corrective actions as necessary.

Requirements

• H.S. Diploma required.
• Understanding of quality requirements (e.g., ISO, FDA regulations) with medical device manufacturing preferred.
• Proficiency in MS Office (Excel, Outlook) preferred.
• Experience in the medical device industry preferred.
• Demonstrated written and verbal communication skills.
• Strong math skills.
• Solid understanding of Quality Systems.

Responsibilities

• Accurately and promptly fill out required forms and paperwork documenting inspection and audit functions.
• Assist in the management of the calibration and environmental monitoring programs.
• Audit Product History Records, Sterilization Records, and other documentation as required, in order to prepare product for release.
• Carry out specialized testing and investigation as assigned to measure and quantify specific quality issues.
• Evaluate and track product returned from the customer per Complaint Handling and Bowl Investigation Procedure.
• Perform inspection on incoming raw material per approved procedures.
• Assist in monitoring supplier quality trends and corrective action.
• Perform routine audits of the molding and assembly operation per QCP's.
• Work with manufacturing to establish corrective action and assure effectiveness.

What This Job Offers

• Job Type: Full-time
• Industry: Plastics and Rubber Products Manufacturing
• Education Level: High school or GED