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Quality Engineer - 18-26749
Ref No.: 18-26749
Location: Franklin Lakes, New Jersey
Position Type:Contract
Shift:First
Job Category:Engineering
Benefits:401K, Dental Insurance, Life Insurance, Medical Insurance, Vision Insurance
Hiring a Contract Quality Engineer
Duration:  6+ Months
*Could be extended based on performance and project requirements.
Client Location:  Franklin Lakes, NJ
Work Schedule:  40 Hours weekly
Pay Rate:  $75.00 Hourly
Benefits: ACA Compliant Medical Insurance

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
To Apply for immediate consideration please send resume to Louis Moliterno at Louis.Moliterno@onboardusa.com and reference job # 18-26749 in the Subject Line and indicate the best times to contact you (please include nights and weekends if needed).
 
**Candidates must complete background and drug screenings before starting any assignment.
 
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.
 
On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.