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, offering deep expertise, decades of experience, and extensive in-house capabilities in engineering, regulatory services, material selection, prototyping, manufacturing, assembly, and packaging.

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. The role ensures adherence to safety, manufacturing, and quality procedures and requirements.

Responsibilities

• Perform inspections and laboratory tests as assigned, including incoming, in-process, and final inspections.
• Address product quality issues and non-conformances.
• Support process compliance and related documentation.
• Provide daily production support and participate in continuous improvement projects.
• Conduct material testing, analysis, and documentation of results.
• Analyze data from inspections or tests to identify trends or areas for improvement.
• Identify non-compliances (product or process) via creation of nonconformances (NC).
• Perform first article inspections and product/process validation activities.
• Create and inspect product identification labels.
• Support document control activities (Agile updates, work package validation, and storage).
• Perform IV lab tests and support customer complaint investigation activities.
• Conduct Device History Record review and product release activities in SAP.
• Provide and communicate accurate information and test data to Production or Engineering upon request.
• Maintain and ensure calibration of testing and inspection equipment.
• Troubleshoot quality issues and collaborate with the team to resolve them.
• Ensure compliance with all safety, regulatory, and quality standards.
• Additional responsibilities may be assigned to support daily Quality department or production activities.

Requirements

• Minimum of a High School Diploma or equivalent required.
• Minimum of 2 years working as a technician or equivalent.
• Knowledge and experience in the medical device industry preferred.
• Experience with cGMP, FDA regulations, and ISO Quality Systems strongly desired.
• Experience in Lean/Six Sigma techniques preferred; Six Sigma Green Belt or ASQ Certification desired.
• Strong analytical and problem-solving experience (DMAIC, 5Ws, Cause-Effect methods preferred).
• Previous participation in 5S events and FMEAs preferred.
• SAP/ERP system experience preferred.

Skills

• Proficiency in reading and interpreting engineering drawings, specifications, dimensioning, tolerances, procedures, and documentation.
• Proficiency in use and understanding of measurement and test equipment, including Gage R&R process.
• Excellent attention to detail, math, analytical, and problem-solving skills.
• Proficient computer skills in Microsoft Office.
• Highly organized self-starter with a detail-oriented approach and drive for quality.
• Excellent verbal and written communication skills.
• Ability to interface directly with employees and internal suppliers.
• “Hands-on” approach towards manufacturing floor involvement.
• Experience with GDP and ISO Quality Systems strongly desired.
• Ability to work in a fast-paced, team-oriented environment.
• Knowledge of validation processes highly preferred.
• Ability to work effectively as part of a team.

Pay

The pay range for this position at commencement of employment is expected to be between $22–31 per hour. Base pay may vary depending on 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, including PTO, short- and long-term disability, and parental leave.