Quality Control Manager for Medical Industry - CEDENT
Franklin Lakes, NJ
About the Job
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:
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
- 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.
Source : CEDENT