Quality Engineer - MedTech Manufacturing

Dielectrics, a UFP Technologies company; Newburyport (MA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, Vision, Life, and Dis

401K with matching contributions

Paid time off and holidays

Job summary

UFP Technologies, Inc. in Newburyport, MA, is hiring a Quality Engineer - Manufacturing to provide technical support across quality, manufacturing and R&D, ensuring compliance with cGMP, ISO 9001, and ISO 13485.

The role emphasizes problem solving, process improvement and data-driven decision making in a regulated setting. The position requires a bachelor's degree in quality/engineering, CQE certification, and experience with ISO13485/21 CFR Part 820; cleanroom and GD&T proficiency are highly

Qualifications

• Bachelor’s degree in Quality Assurance, Engineering, or Technology with 5 years of quality/manufacturing in regulated industry.
• CQE certification; additional 10 years of experience considered.
• Experience in ISO 13485 and 21 CFR Part 820 required.
• ISO 9001 or AS 9100 preferred.
• Thorough understanding of statistical process control and process capability.
• Cleanroom experience is required.
• GD&T certification is preferred.
• cGMP experience is preferred.

Responsibilities

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

Skills

Statistical process control

GD&T

Process capability

Quality improvement

Education

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

CQE certification

Job description

UFP Technologies, Inc. in Newburyport, MA, is hiring a Quality Engineer - Manufacturing to provide technical support across quality, manufacturing and R&D, ensuring compliance with cGMP, ISO 9001, and ISO 13485.

The role emphasizes problem solving, process improvement and data-driven decision making in a regulated setting. The position requires a bachelor's degree in quality/engineering, CQE certification, and experience with ISO13485/21 CFR Part 820; cleanroom and GD&T proficiency are highly