INGENYX-Quality Technician
About The Position
Ingenyx, a new independent company spun off from Teleflex, is a leading global provider of product development and production services for medical device manufacturers. We specialize in engineering, regulatory services, material selection, prototyping, manufacturing, assembly, and packaging for a variety of medical devices including extrusions, catheters, balloons, sheath/dilator sets, sutures, braids, and fibers. We are seeking a Quality Technician to perform product inspections and testing, implement controls, standards, procedures, and corrective actions to support the manufacturing processes and the Teleflex Medical Quality System.
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 a fast-paced, team-oriented work environment.
- Ability to work as part of an effective team and achieve site-level continuous improvement goals.
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 Good Documentation Practices (GDP).
- Perform routine laboratory testing as assigned.
- Perform label printing, label inspection, and label verification activities.
- Perform Device History Record (DHR) review, compile data, scan DHRs, and file documents accordingly.
- Assist with scanning and filing of calibration records and calibration activities.
- Perform product release using the 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 Nonconformance (NC) process.
- Perform First Article Inspections (FAI) for product/process validation.
- Read and interpret protocols, procedures, and sample requests and adhere to the requirements.
- Support process compliance and related documentation.
- Participate in continuous improvement projects (e.g., 5S).
- Support creation and maintenance of calibration records/plans.
- Support creation and updating of Quality Management System (QMS) documents.
- Adhere to safety, Quality, and manufacturing site requirements.
- Additional responsibilities may be assigned to support daily Quality department or production activities.
Benefits
- Medical insurance
- Prescription drug insurance
- Dental insurance
- Vision insurance
- Flexible spending accounts
- Participation in 401(k) savings plan
- Paid time off (PTO)
- Short-term disability
- Long-term disability
- Parental leave
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
