| |
Randstad Engineering
|
|
|
| |
Job Location: JACKSONVILLE, TX
|
| |
Medical Device Company needs a Project Manager with a proven track record of meeting quality and regulatory performance requirements of the Medical Device Directive, ISO 13485:2003, CMDR, and FDA (i.e. QSR) in the quality elements. Must have sourcing skills movings products from one site of manufacture to another. The Project Manager is responsible for the management and execution of sourcing programs and projects consisting of single or multiple projects and programs. The Engineer will have Medical Device experience medical devices: Sterilization (gamma and ethylene oxide), Packaging (distribution testing and sterile barrier),Material Clearance for Use (biocompatibility), Labeling. The Engineer will also have experience working with the FDA and Quality Engineering. This a Contract position with Direct Hire potential.
Responsibilities:
-> Management and execution of sourcing programs and projects consisting of single or multiple projects and programs
-> Responsible for documenting the responsibility, authority, and interrelationship of all appropriate personnel who perform and verify work affecting quality and regulatory compliance.
-> Alerts the Quality Assurance and Regulatory Affairs departments to significant quality and regulatory issues .
-> Works on complex projects of medium to large scope which involving Quality, Regulatory Affairs, Planning and Inventory Control, Global Trade, foreign subsidiaries, Marketing,and Global Sourcing,
-> Applies comprehensive knowledge and a thorough understanding of the concepts, principles, and requirements surrounding the design, manufacture, sale, export, and importation of medical devices to perform varied tasks is support of assigned projects.
-> Compliance with QPLs governing design control, risk management, process validation, labeling, and other applicable policies which govern contract manufacturing and private label product procurement
Requirements:
-> BS Science or Engineering and 4 years medical devices manufacturing process project management experience
-> Knowledge of design control regulations as promulgated by the U.S. Food and Drug Administration and the Medical Device Directive of the European Union
-> Knowledge of FDA regulations surrounding Good Manufacturing Practices as they apply to manufacturing medical devices
-> Knowledge of manufacturing methods including plastics processing, manual assembly, automated assembly, and sterile and non-sterile packaging
-> Familiar with Microsoft, Computer Aided Design
-> Willing to travel 20%
-> Fluency in Spanish is a plus
Benefits:
-> Benefits, 401K, PTO
Related Words: medical device, iso 13485:2003, medical regulations, regulatory performance, medical devices, sterilization, gamma, ethylene oxid, packaging, distribution testing, sterile barrier, material clearance for use, biocompatibility, labeling, quality, regulatory affairs, planning and inventory control, global trade, foreign subsidiaries, marketing, global sourcing, design control, risk management, process validation, labeling, contract manufacturing, private label, product procurement, six sigma, six-sigma, 6 sigma, 6-sigma, sigma black belt, sigma black belts, master black belts, black belt, master black belt, master blackbelt, master blackbelts, green belt, project management, gannt, sourcing, sourcing components
Randstad Engineering
|
| |
See all jobs in Jacksonville TX
|
|
|
Share this job
|
|
|
|
|
|
Business News, Wedding Dresses, Study Tips, Diablo 3 Gold, D3 Gold, Diablo 3 Power Leveling, Replica Handbags, Replica Bags, Fashion News, Fashion Bags, Fashion Women Bags, Fashion Tips, Fashion Shoes, Swtor Credits, Swtor Gold, Guild Wars 2 Gold, GW2 Gold, Guild Wars 2 Power Leveling, Diablo 3 Gold, Guild Wars 2 Gold, RS Gold, WoW Gold Kaufen, Website Design, Swtor Credits, RS Gold, Adidas Shoes, Nike Shoes, Diablo 3 Gold, Swtor Credits, Rift Platinum, MBT Shoes, Tera Gold, Replica Watches, WoW Gold
| |
