Quality Engineer - Medical Devices (NPD & Supplier Quality)

Intellectt INC; Raynham (MA); On-site; USD 55,000 - 65,000; Full time

Job summary

Intellectt INC is seeking a Quality Engineer in Raynham, MA for a 15-month onsite assignment. The role requires hands-on experience with design controls, risk management, and supplier collaboration to support an new product development project.

The candidate will review and update DHFs, risk reports, traceability matrices, and validation documentation, while ensuring GDP and cross-functional quality standards are maintained throughout the project lifecycle.

Qualifications

• Experience in medical device quality engineering and New Product Development.
• Proven ability to interface with suppliers and external partners.
• Familiarity with GDP, design controls, and DFMEA.
• Skilled in risk management, process verification/validation, and CTQ cascading.

Responsibilities

• Review, approve, and execute updates to DHFs and risk management reports.
• Create and maintain traceability matrices and PVE/validation documentation.
• Draft and issue protocols, reports, and change control plans.
• Assess cross-functional impact of changes and communicate quality requirements.

Skills

Quality Eng

NPD

Supplier Quality

Risk Management

Design Quality

Process Verification

Process Validation

Gauge R&R

Communication

Job description

Intellectt INC is seeking a Quality Engineer in Raynham, MA for a 15-month onsite assignment. The role requires hands-on experience with design controls, risk management, and supplier collaboration to support an new product development project.

The candidate will review and update DHFs, risk reports, traceability matrices, and validation documentation, while ensuring GDP and cross-functional quality standards are maintained throughout the project lifecycle.