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Quality Engineer in Franklin Lakes, NJ at Integrated Resources, Inc

Date Posted: 2/11/2019

Job Snapshot

Job Description

Rate of pay = ***/hr
6 month assignment, but could be extended based on temp performance and project requirements.

Objective

Individual with proven project execution experience in quality engineering, design control and risk management for a market leader in the medical device industry. Assist in special assignment to support design history file gap assessment and potentially remediation.

Summary of Skills

Extensive practical knowledge of quality engineering and design/development activities for medical devices.
In-depth knowledge of the concepts of design control, engineering change control, statistical techniques, design verification and validation, risk management, design history files (DHF), device history and master records (DHR/DMR), CAPA, 510(k), etc.
Audit experience is a plus
Production and process controls knowledge and experience.
Quality engineering concepts such as measurement and calibration systems, quality testing, sampling and inspection, process control, process validation, SOPs, engineering change notices etc.
Sound knowledge of FDA Quality System Regulations; 21 CFR Part 820 (Part 210 & 211 knowledge/experience is a plus).
Sound knowledge of ISO 13485 for medical devices
Knowledge of basic computer applications, Microsoft suite of tools (Word, Excel, Power Point etc.), Minitab for statistical analysis, SAP a plus
Can communicate effectively, verbal and written
Must be able to work under minimal supervision on somewhat ambiguous tasks

Work Experience

Medical Device Quality Engineer
Minimum eight (8) years of experience within FDA regulated medical device and/or pharmaceutical industry with knowledge of FDA and ISO regulations
Education and Certifications
Bachelor's Degree in a scientific discipline
ASQ CQE, CQA, Six Sigma certification a plus