INGENYX- Quality Technician

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Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters;

balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

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.

• 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.

• 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.

The pay range for this position at commencement of employment is expected to be between $22-31 per hour, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered.

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