Quality Engineer, Manufacturing – Medical Devices

Ufp-Technologies; Newburyport (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

UFP Technologies, Inc. is hiring a Quality Engineer for our Newburyport, MA site. The role provides technical support to Quality, Manufacturing, and R&D in corrective actions, product conformity, and audits within a cGMP, GDP environment.

You will investigate nonconforming products, drive CAPAs, and assist with process control, metrology, calibration, and supplier quality activities, supporting Lean initiatives and product launches.

Qualifications

• Bachelor’s degree in Quality Assurance, Engineering, or Technology, with 5 years of quality or manufacturing experience in regulated industry.
• CQE certification; 10 years’ experience will be considered.
• Experience in ISO 13485 and 21 CFR Part 820 required; ISO 9001 or AS 9100 preferred.
• Cleanroom experience required; GD&T certification preferred.

Responsibilities

• Supports, upholds and enforces compliance with ISO 9001, ISO 13485 and AS9100 regulations.
• Investigates and documents customer returns, complaints and nonconforming products.
• Implements measurable, effective corrective & preventive actions.
• Provides guidance for manufacturing, engineering, materials, customers and suppliers in quality performance.
• Supports product development and production transfer activities.

Skills

Quality engineering

Regulated industry

Statistical process control

cGMP

GD&T knowledge

Education

Bachelor’s degree in Quality Assurance, Engineering, or Technology

Tools

GD&T

Job description

UFP Technologies, Inc. is hiring a Quality Engineer for our Newburyport, MA site. The role provides technical support to Quality, Manufacturing, and R&D in corrective actions, product conformity, and audits within a cGMP, GDP environment.

You will investigate nonconforming products, drive CAPAs, and assist with process control, metrology, calibration, and supplier quality activities, supporting Lean initiatives and product launches.