Senior Manufacturing Quality Engineer – Med Devices

Teleflex

Town of Mansfield (NY)

On-site

USD 111,000 - 138,000

Full time

9 days ago

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Benefits offered by this job

Medical insurance
Dental insurance
Vision insurance
401(k)

Job summary

Ingenyx is seeking a Manufacturing Quality Engineer III to support manufacturing operations on the floor, drive process robustness, and lead validation activities across IQ/OQ/PQ and TMV. You will analyze data, investigate root causes, and collaborate with cross‑functional teams to improve yield and ensure compliance with FDA/ISO requirements.

The role requires 5–8 years in a regulated manufacturing environment, strong problem-solving skills, and experience with calibration, metrology, and

Qualifications

  • Bachelor's Degree in a technical discipline (Mechanical/Manufacturing/Industrial/Biomedical)
  • Minimum 5–8 years of engineering experience in a regulated manufacturing environment.
  • Experience with process validation, calibration systems, and manufacturing equipment.

Responsibilities

  • Provide day-to-day quality engineering support for manufacturing operations.
  • Monitor and improve process performance and product quality.
  • Lead process validation activities (IQ/OQ/PQ) and TMV.
  • Support equipment qualification and lifecycle management.
  • Analyze data to identify trends, risks, and improvements.
  • Lead root cause investigations for manufacturing processes and equipment issues.
  • Ensure processes remain in a validated state with routine monitoring.

Skills

Root cause analysis
Process improvement
Cross-functional teamwork
Statistical analysis
Troubleshooting

Education

Bachelor's Degree in Mechanical Engineering
Bachelor's Degree in Manufacturing Engineering

Tools

Power BI
Excel (Advanced)
Python
R
QI Macros

Job description

Ingenyx is seeking a Manufacturing Quality Engineer III to support manufacturing operations on the floor, drive process robustness, and lead validation activities across IQ/OQ/PQ and TMV. You will analyze data, investigate root causes, and collaborate with cross‑functional teams to improve yield and ensure compliance with FDA/ISO requirements.

The role requires 5–8 years in a regulated manufacturing environment, strong problem-solving skills, and experience with calibration, metrology, and

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