My name is Srinivas with PamTen Inc, Our records show that you are an experienced IT professional with experience in Quality Assurance. This experience may be relevant to one of my current openings. I have a client located in NJ who is looking for candidates with the following skills for a Fulltime position. Please reply back to me with your updated resume and contact details if you are available and comfortable. Position: Senior Quality Engineer Industry: Medical Equipment / Devices Department: Manufacturing - Quality Type: Permanent Location: Plainsboro, New Jersey. DESCRIPTION: 7+ to 10 years of experience Minimum Education - Bachelor's Degree RESPONSIBILITIES: · Provide Plant Quality compliance support for the following Quality tasks and duties: Introduction and launching of new or improved processes and methods to the manufacturing facility. Lead problem solving teams. Provide leadership and training in statistical methods and data analysis. Coordinate efforts to develop and update Quality System documents for ISO/QSR compliance. Write and review validation protocols, manufacturing procedures, quality plans, validation plans, commissioning documents, SOPs etc. to support the build-out and scale-up of new faculties. Support all quality system activities leading to improved compliance with corporate policies, 21CFR820, ISO 9001, ISO 13485, ISO 14971, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies. · Write and/or coordinate development of new and updated Quality System documents to assure compliance to US/EU/etc. compliance. · Write and execute validation documents · Develop statistically valid sampling plans for QC and validation activities · Work with project teams to develop DOEs and statistically sound tests for appropriate support of results. · Develop, review, and approve validations and completion reports. Provide statistical analysis of the data to support the reports. · Ensure that all projects are in compliance with GLP, QSR (including Design Controls), ISO or other applicable requirements. · Formulate product quality plans based on results of risk analysis · Support as required the Quality Management Review Process · Support corporate Regulatory Affairs by providing information for submissions and Annual Reports. · Interact and coordinate activities with other departments, external vendors and customers. · Work with Product Development team in order to ensure all aspects of Design Transfer activities are being met. · As required, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective & Preventative Action(s) (CAPA support) · Develop and implement SPC control system with Manufacturing and Quality Control. · Develop quality system metrics to support Management Reviews · Lead product complaint investigations. · Mentor others in statistical methods JOB REQUIREMENTS: · Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical), Master's degree preferred. · Minimum of 7 years experience in a Quality Assurance role for medical device or pharmaceutical manufacturing (or 5 years with Masters Degree) · Demonstrates excellent knowledge of statistical sampling and analysis, including DOE design. · Demonstrates excellent math, organizational and communication skills, proficiency with MS Office Suite, and statistical software. · Must be able to work independently with minimal supervision. · Must exhibit good working knowledge of statistics including coming up with statistical rationales for validations · Able to perform risk analyses including FMEA's · Able to prioritize projects and manage Quality Engineering resources to meet organizational goals and objectives · Able to mentor and train Junior staff and other disciplines · Able to lead projects of significant complexity Srinivas Gadde PamTen, Inc 732 419 2508 srinivas.gadde@pamten.com www.pamten.com MIS Ntwk Assoc Mtg Dates: Nov 8th - Tues Reg Mtg - 6 pm - Berman Larson Kane Offices, Paramus - DO NOT use GPS for directions - Get dir from BLK site - Bring 15 copies of your resume Nov 29th - Your Career Night Out Panel - Dinner Mtg - Bill Belknap Moderator, Janelle Razzino Razzino Associates - Marty Latman CIT/FENG/SENG - Alex Freund Landing Expert - Cathy Love Fairleigh Dickinson - Diane Young LYF Experience |
__._,_.___
MARKETPLACE
.
__,_._,___
No comments:
Post a Comment