Quallity Engineer

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

Role: Quality Engineer
Location: Raynham, MA.
Duration: 15 months
Work Arrangement: Onsite
Rate: $40 - 47/hr on w2

Environment

Our client is a large Medical Device manufacturer of orthopedic products. They need are seeking an experienced Quality Engineer to support a new product development project. This candidate should have experience with design controls, risk management, process verification, and working with suppliers.

Project Scope & Responsibilities

The client is looking for someone who has experience interfacing with suppliers and external partners. This candidate should be experienced with all Quality activities related to NPD and design quality which will include reviewing, approving, and executing updates to DHFs, risk management reports, traceability matrices, and process verification/validation documentation. The candidate should have a strong ability within Good Documentation Practices (GDP).

This individual should have strong experience ensuring quality standards are cascaded, communicated, and documented; strong experience drafting protocols/reports/change control plans, assessing Quality and cross functional impacts due to changes, cascading CTQs, and acting as Quality SME on project teams managing supplier/design transfers. Additionally, this candidate should be a self-starter who has strong attention to detail, and the ability to manage and drive all tasks to completion with no or very minimal oversight.

Required

• Medical Device
• Quality Engineering
• New Product Development
• Supplier Quality - Experience Interfacing with Suppliers
• Risk Management
• Design Quality (dFMEA)
• Process Verification + Validation (Executing PVE's)
• Gauge R&R
• Strong communication skills