INGENYX-Quality Technician

Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026. Ingenyx is a leading global provider of product development and production services for medical device manufacturers, delivering industry-changing innovations and next-generation solutions for extrusions, diagnostic and interventional catheters, balloons and balloon catheters, sheath/dilator sets, specialty sutures, braids, fibers, and bioabsorbable sutures, yarns, and resins.

About the role

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

Expected travel: Up to 10%

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, compile data, DHR scanning, and filing documents accordingly.
• Assist with scanning and filing of calibration records and calibration activities.
• Perform product release using SAP system.
• Ensure test equipment is calibrated and functioning properly (when required).
• Assist with training and guiding other employees to support continuous improvement goals.
• Identify non-compliances (product or process) via creation of nonconformances using the NC process.
• Perform First Article Inspections (FAI) for product/process validation.
• Read and interpret protocols, procedures, and sample requests, adhering to the requirements.
• Support process compliance and related documentation.
• Participate in continuous improvement projects (5S).
• Support creation and maintenance of calibration records/plans.
• 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.

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.

Skills

• Strong analytical and problem-solving skills.
• Proficient computer skills in Microsoft Office.
• Highly organized self-starter who is detail-oriented with drive and enthusiasm for quality.
• Ability to work in a fast-paced, team-oriented work environment.
• Ability to work as part of an effective team and achieve site-level continuous improvement goals.

Pay

The pay range for this position at commencement of employment is expected to be between $22.45–$31.44 per hour. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

Benefits

• Medical, prescription drug, dental, and vision insurance.
• Flexible spending accounts.
• Participation in 401(k) savings plan.
• Various paid time off benefits, such as PTO, short- and long-term disability, and parental leave.