Senior Manufacturing Quality Engineer - Process Validation

Teleflex; Mansfield (MA); On-site; USD 111,000 - 138,000; Full time

Benefits offered by this job

Medical, prescription, dental and vis

401(k) and retirement benefits

Paid time off (PTO)

Disability and parental leave

Job summary

Ingenyx is seeking a Manufacturing Quality Engineer III to support our production floor with quality engineering, validation, and calibration oversight. You will work with Manufacturing, Operations, Engineering, and Quality teams to improve process robustness and product quality on a busy line.

You will lead investigations, monitor process capability, and drive continuous improvement while ensuring compliance with FDA, ISO 13485, and cGMP requirements. Travel <30% may be required.

Qualifications

• Bachelor’s degree in a technical discipline with manufacturing experience.
• Experience supporting manufacturing equipment, validation, and calibration.
• Strong problem solving and data analysis skills.
• Experience in medical device manufacturing preferred.

Responsibilities

• Provide day-to-day quality engineering support for manufacturing operations.
• Lead process validation activities (IQ/OQ/PQ) and TMV.
• Monitor process capability and drive yield improvements.
• Lead root-cause investigations on quality issues and CAPA.
• Collaborate with cross‑functional teams on equipment and process improvements.
• Ensure validated state and compliance with FDA/ISO requirements.

Skills

Statistical analysis

Root cause analysis

Cross-functional collaboration

Troubleshooting equipment

Problem solving

Education

Bachelor’s Degree in Mechanical Engineering

Engineering in a regulated manufacturing environment

Tools

Power BI

QI Macros

Excel

Python

R

Job description

Ingenyx is seeking a Manufacturing Quality Engineer III to support our production floor with quality engineering, validation, and calibration oversight. You will work with Manufacturing, Operations, Engineering, and Quality teams to improve process robustness and product quality on a busy line.

You will lead investigations, monitor process capability, and drive continuous improvement while ensuring compliance with FDA, ISO 13485, and cGMP requirements. Travel <30% may be required.