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