INGENYX-Quality Technician

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- Quality Technician (Coventry, CT)

Position Summary

This position is responsible for performing product inspections and testing, implementing controls, standards, procedures and corrective actions in support of the Teleflex Medical Quality System and manufacturing processes.

Principal 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 activities.
• Perform DHR review, compiled data, DHR scanning and filing documents accordingly.
• Perform product release using SAP system.
• Ensuring test equipment is calibrated and functions properly when required
• Assist with training and guiding other employees to support continuous improvement goals.
• Identification of non-compliances (product or process) via creation of nonconformances using (NC) process.
• Perform First Article Inspections (FAI) for product/process validation.
• Ability to read and interpret protocols, procedures, and sample requests and adhere to the requirements.
• Support process compliance and related documentation.
• Participate in continuous improvement projects. (5s)
• Support creation and updating of QMS documents.
• Adhere to safety, Quality, and manufacturing site requirements.
• Additional responsibilities may be assigned to support daily Quality department or production activities.

Education / Experience Requirements

• Minimum of a High School Diploma or equivalent required
• Knowledge and experience working in Quality Assurance/ Testing field, strongly desired.
• Knowledge and experience working in the medical device industry preferred.
• Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired.
• Strong analytical & problem-solving skills.
• Proficient computer skills in Microsoft Office
• Highly organized self-starter who is detailed oriented with drive and enthusiasm for quality.
• Ability to work in fast paced, team-oriented work environment.
• Ability to work as part of an effective team and achieve site level continuous improvement goals.