Title: Quality Control Manager for Medical Industry @ Franklin Lakes, NJ
Terms of Hire: 6 months Contract.
Job Responsibilities
Title: Quality Control Manager for Medical Industry @ NJ
Duration: 6 months contract
Job description
Objective:
Individual with thorough experience in quality engineering, quality systems, validation, risk management and design control for a market leader in the medical device industry.
Summary of skills:

• Extensive knowledge of quality engineering, and or quality systems for medical devices

• In-depth knowledge of the concepts of; design control, engineering change control, statistical techniques, verification and validation methods/protocols, risk management, design history files (DHF), device history and master records (DHR/DMR), CAPA, 510(k), complaint handling etc.

• Well-versed in the methodologies of verification and validation for medical devices

• Sound knowledge of FDA Quality System Regulations; 21 CFR Part 210, 211, especially 21 CFR Part 820 and 21 CFR 820.198 etc. Knowledge of the European Medical Device (MDR) regulations a plus

• Sound knowledge of ISO13485 for medical devices

• Quality engineering concepts such as; statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, engineering change notices etc.

• Audit experience a plus

• Knowledge of basic computer applications, Microsoft suite of tools (Word, Excel, Power Point etc.), Minitab for statistical analysis, SAP and Trackwise systems a plus

Can communicate effectively

• Must be able to work under minimal supervision on somewhat ambiguous tasks

. You Will Enjoy:

• An opportunity to be a part of a great culture, an awesome team, a challenging work environment, and some fun along the way!

• Apply today to learn more and be part of our Growth story.

All applications will be kept strictly confidential and once shortlisted, our team will be in touch with you for further discussions.