INGENYX- Quality Engineering Technician

Teleflex Incorporated; Mansfield (MA); On-site; USD 40,000 - 59,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Paid Time Off

Job summary

Ingenyx, a leading medical device-focused development and production provider, is seeking a Quality Engineering Technician in Mansfield, MA. This hands-on role supports engineering operations, validation activities, and continuous improvement with cross-functional teams including Manufacturing, Operations, Engineering and Quality.

Expect a fast-paced environment emphasizing change with accuracy and process robustness.

Qualifications

• Associate's or Bachelor's Degree in Engineering, or related technical discipline.
• Minimum 1 year of quality or manufacturing experience in a regulated environment.
• Preferred: Experience with data analysis, non-conformance investigation, and authoring of protocols and reports.

Responsibilities

• Provide day-to-day quality support for engineering operations. Track and communicate project status.
• Assist in quality engineering tasks, such as data analysis, investigations into potential non-conformance or complaints, or validation activities (TMV, IQ/OQ/PQ).
• Author or co-author engineering, validation, and/or qualification protocols and reports.
• Quality support functions include execution or preparation of quality plans, documentation retrieval during audits, qualification/validation protocols and reports, routing/review/revision of documentation as needed.
• Support manufacturing by reviewing production documentation for completeness and correctness.

Skills

Power BI

QI Macros

Excel (Advanced)

Python

R

Root cause analysis

Cross-functional collaboration

Data analysis

Education

Engineering degree

Tools

Excel

Python

R

Power BI

Job description

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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. 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.

Quality Engineering Technician is a hands-on engineering support role responsible for planning and executing process monitoring, equipment oversight, validation activities, and continuous improvement initiatives with guidance from Quality Engineering. This position works closely with Manufacturing, Operations, Engineering, and Quality teams to drive process robustness, improve product quality, reduce variation, and ensure compliance with applicable quality system and regulatory requirements.

The ideal candidate is capable of decisive, swift and precise execution of change with an eye for detail & improvement and brings with them an enthusiastic demeanor.

• Provide day-to-day quality support for engineering operations. Track and communicate project status.
• Assist in quality engineering tasks, such as: data analysis, investigations into potential non-conformance or complaints, or validation activities (TMV, IQ/OQ/PQ).
• Author or co-author engineering, validation, and/or qualification protocols and reports.
• Quality support functions include execution or preparation of quality plans, documentation retrieval during audits, qualification/validation protocols and reports, routing/review/revision of documentation as needed.
• Support manufacturing by reviewing production documentation for completeness and correctness.
• Submit or fulfill engineering change orders, including process change or improvement activities.
• Acquire and analyze manufacturing and quality data to identify trends, risks, and improvement opportunities.
• Assist in technical root cause investigations related to manufacturing processes, equipment performance, and product quality issues.
• Assist in maintenance of the calibration program, including investigation of calibration abnormalities or filing of metrological paperwork.
• Collaborate with Manufacturing Engineering on equipment, tooling, automation, and process improvement projects.
• Participate in risk assessments and implementation of risk mitigation activities.
• Support transfer of new products and processes into manufacturing.
• Participate in and propose operational excellence activities to reduce scrap, enhance efficiency, and improve quality.
• Ensure compliance with applicable company procedures, FDA regulations, ISO 13485 requirements, and customer expectations.
• Updates procedures, work instructions, or other documentation, and leads change orders to execute updates as needed.

Education / Experience Requirements

• Associate's or Bachelor's Degree in Engineering, or related technical discipline.
• Minimum 1 year of quality or manufacturing experience in a regulated environment.
• Preferred: Experience supporting manufacturing, calibration, or qualify systems.
• Preferred: Experience in medical device manufacturing.
• Preferred: Experience with data analysis, non-conformance investigation, and authoring of protocols and reports.

Specialized Skills / Other Requirements

• Knowledge of root cause analysis tools and problem-solving methodologies.
• Knowledge of FDA QMSR, ISO 13485, and cGMP requirements.
• Ability to work effectively in cross-functional teams and communicate technical information clearly.
• Strong organizational, analytical, and problem-solving skills.
• Proficiency in Microsoft Office applications and data analysis tools, such as Power BI, QI Macros, Excel (advanced), Python, or R.
• Preferred: Understanding of SPC, process capability studies, and data analysis techniques.
• Preferred: Experience with handling non-conformances.

The pay range for this position at commencement of employment is expected to be between $28.70-43.07 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. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

At Ingenyx, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Ingenyx is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or [e-mail].