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Quality Engineer - III (New Product Development)

Company:
LanceSoft INC
Location:
Raynham, Massachusetts, United States
Posted:
December 05, 2016
Description:

Core Responsibilities

NPD Engineering will support new product development projects varying scope and complexity across the total Codman Business – Neuro Surgery and Neuro Vascular

• Core team member of cross-functional teams focused on NPD or design changes on existing products and base business projects

• Knowledge of Product Development / Design Controls / Design Change processes

• Knowledge and execution of Risk Management processes and tools

• Strong analytical skills

• Travel up to 10% of the Time

Qualifications

• Bachelor’s Degree required, with preference for Engineering

• Experience in the medical device industry and knowledge in FDA QSR and ISO13485 requirements is preferred

• Experience in Pharma CGMP 210/211, Combination Product 21 CFR Part 4 is preferred

• Minimum of 5 years of related experience

Key Competencies

• Teaming and collaboration, including building strong cross-functional relationships

• Ability to management multiple projects

• Problem-solving

• Strong written and verbal communication skills as well as presentation and analytical/statistical skills are required.