Medical Device Quality Technician | QA & Inspection

Ingenyx Limited; Coventry (CT); On-site; USD 55,000 - 75,000; Full time

Job summary

Ingenyx Limited in Coventry, CT is seeking a Quality Technician to perform product inspections and testing, implement controls, and support the Teleflex Medical Quality System. You will conduct QA activities across incoming, in-process, and final release, and assist with non-conformances and continuous improvement.

The role requires a high school diploma and experience in QA/testing, preferably in the medical device field, with knowledge of cGMP, FDA regulations, and ISO QMS.

Qualifications

• High school diploma or equivalent required.
• Experience in Quality Assurance/Testing preferred.
• Experience with the medical device industry preferred.
• Knowledge of cGMP, FDA regulations and ISO QMS preferred.
• Strong analytical and problem-solving skills.
• Proficient with Microsoft Office.

Responsibilities

• Conduct quality assurance activities, inspections, and testing for incoming, in-process, and final release.
• Support customer complaint testing activities.
• Ensure all documentation is performed per GDP.
• Perform routine laboratory testing as assigned.
• Perform label printing, label inspection, and label verification.
• Perform DHR review and scanning of documents.
• Release product using SAP system.
• Ensure test equipment is calibrated and functioning properly.
• Assist with training and guiding others for continuous improvement.
• Identify non-conformances via NC processes.
• Perform First Article Inspections for validation.
• Read and interpret protocols and procedures and adhere to requirements.
• Support process compliance and related documentation.
• Participate in continuous improvement projects (5S).
• Assist with updating QMS documents.
• Adhere to safety, quality and site requirements.

Skills

Analytical

Problem solving

Detail oriented

Education

High School diploma

Tools

SAP

Microsoft Office

Job description

Ingenyx Limited in Coventry, CT is seeking a Quality Technician to perform product inspections and testing, implement controls, and support the Teleflex Medical Quality System. You will conduct QA activities across incoming, in-process, and final release, and assist with non-conformances and continuous improvement.

The role requires a high school diploma and experience in QA/testing, preferably in the medical device field, with knowledge of cGMP, FDA regulations, and ISO QMS.