Configuration Management Engineer
Company Name:
Artech Information Systems, LLC
Reference # : 14-33153 Title : Configuration Management Engineer
Location : Portsmouth, NH
Experience Level : Start Date / End Date : 10/13/2014 / 04/30/2015
Description
Job
Summary:
Company: Artech Information Systems LLC
Job Title: Configuration Management Engineer / Document Control
Job ID: 45257
Location: Portsmouth, NH
Duration: 6 Months
Job Duties:
Participates in Design and Code Reviews
Urgent request! Sr. Configuration Management Specialist
Looking for someone who understands configuration management. This position has the responsibility and authority to provide moderate expertise in the areas of configuration management, control, planning, and consulting.
The Configuration Management Specialist is responsible for performing tasks that will drive the timely release and change of product documentation, Quality Management System documents, and supporting data throughout the product's lifecycle. Manages the MRP system controlling engineering and manufacturing documentation, such as drawings, bills of materials (BOM), parts lists specifications and engineering change orders. Ensures that master drawing files and device and design history files and records are accurate and current, and that effective control is maintained over drawings and other document records. In addition, supports Quality System audits, CAPA, quality system training.
Responsibilities:
Responsible for following and ensuring that personnel follow Good Manufacturing Practices and SOP's as defined by Healthcare policies, practices and procedures to ensure that Food and Drug Administration and ISO/MDD regulations, Healthcare and other applicable standards are consistently met. Is required to perform compliance review of quality system document submissions (ECN & CAR) to our QMS requirements. Identify any non-compliance & effectively communicate to requestors in a clear and concise manner these discrepancies, monitor and trend these occurrences.
Facilitate the timely change, approval and release of product documentation and data to include ECN's, Device Master Record authorization documents, product/model numbers, modifications to material & product BOM & RTG (Router), DIR. Master data, information in SAP, manufacturing processes, and document archiving.
Facilitate the timely change, approval and release of Quality System documents to include SOP's, Quality Forms, Quality Manual, and Sector SOP's. This includes Route Administration for all QMS document actions within the Document Management Application; assisting with hands on customer service support for document creation, formatting, editing, content structure, QMS impact assessment, routing and approval process, collaboration with the L&D Department for training record documents.
Requirements:
Bachelor's degree preferred, preferably in engineering, business, information systems or health sciences.
YEARS OF EXPERIENCE
Five years of relevant configuration management experience
CMII certification preferred.
Demonstrated ability to complete assignments of increasing complexity
Strong understanding and working knowledge of computer databases and systems
SPECIALIZED KNOWLEDGE
Strong understanding of FDA, and ISO QS standards.
Priya Mehrotra
Sr. Executive Staffing
Artech Information Systems LLC
240 Cedar Knolls Road, Suite 100 - Cedar Knolls, NJ 07927
Office - Fax
Email:Priya. -
About Artech Information Systems LLC
Artech is an employer-of-choice for over 5,800 consultants across the globe. We recruit top-notch talent for over 65 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the U.S. and this may be your opportunity to join us!
Want to read more about Artech?
Clickhereto visit our website or click on the following links to read what others are saying about us:The Wall Street Journal,Forbes (1)(2),BusinessWire,Entrepreneur,Better Business Bureau,Hoovers,Diversity Careers(1)(2),The Artech Circle,NJTVOnline,The Business Forum Show, andSIA: Above the Crowd.
Connect with Artech through Social Media
Learn more about our company including the latest events at Artech, new job opportunities, jobseeker tips, and more. Follow us onFacebook,Google+,LinkedIn,Pinterest,Twitter, andYouTube.Estimated Salary: $20 to $28 per hour based on qualifications.
Artech Information Systems, LLC
Reference # : 14-33153 Title : Configuration Management Engineer
Location : Portsmouth, NH
Experience Level : Start Date / End Date : 10/13/2014 / 04/30/2015
Description
Job
Summary:
Company: Artech Information Systems LLC
Job Title: Configuration Management Engineer / Document Control
Job ID: 45257
Location: Portsmouth, NH
Duration: 6 Months
Job Duties:
Participates in Design and Code Reviews
Urgent request! Sr. Configuration Management Specialist
Looking for someone who understands configuration management. This position has the responsibility and authority to provide moderate expertise in the areas of configuration management, control, planning, and consulting.
The Configuration Management Specialist is responsible for performing tasks that will drive the timely release and change of product documentation, Quality Management System documents, and supporting data throughout the product's lifecycle. Manages the MRP system controlling engineering and manufacturing documentation, such as drawings, bills of materials (BOM), parts lists specifications and engineering change orders. Ensures that master drawing files and device and design history files and records are accurate and current, and that effective control is maintained over drawings and other document records. In addition, supports Quality System audits, CAPA, quality system training.
Responsibilities:
Responsible for following and ensuring that personnel follow Good Manufacturing Practices and SOP's as defined by Healthcare policies, practices and procedures to ensure that Food and Drug Administration and ISO/MDD regulations, Healthcare and other applicable standards are consistently met. Is required to perform compliance review of quality system document submissions (ECN & CAR) to our QMS requirements. Identify any non-compliance & effectively communicate to requestors in a clear and concise manner these discrepancies, monitor and trend these occurrences.
Facilitate the timely change, approval and release of product documentation and data to include ECN's, Device Master Record authorization documents, product/model numbers, modifications to material & product BOM & RTG (Router), DIR. Master data, information in SAP, manufacturing processes, and document archiving.
Facilitate the timely change, approval and release of Quality System documents to include SOP's, Quality Forms, Quality Manual, and Sector SOP's. This includes Route Administration for all QMS document actions within the Document Management Application; assisting with hands on customer service support for document creation, formatting, editing, content structure, QMS impact assessment, routing and approval process, collaboration with the L&D Department for training record documents.
Requirements:
Bachelor's degree preferred, preferably in engineering, business, information systems or health sciences.
YEARS OF EXPERIENCE
Five years of relevant configuration management experience
CMII certification preferred.
Demonstrated ability to complete assignments of increasing complexity
Strong understanding and working knowledge of computer databases and systems
SPECIALIZED KNOWLEDGE
Strong understanding of FDA, and ISO QS standards.
Priya Mehrotra
Sr. Executive Staffing
Artech Information Systems LLC
240 Cedar Knolls Road, Suite 100 - Cedar Knolls, NJ 07927
Office - Fax
Email:Priya. -
About Artech Information Systems LLC
Artech is an employer-of-choice for over 5,800 consultants across the globe. We recruit top-notch talent for over 65 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the U.S. and this may be your opportunity to join us!
Want to read more about Artech?
Clickhereto visit our website or click on the following links to read what others are saying about us:The Wall Street Journal,Forbes (1)(2),BusinessWire,Entrepreneur,Better Business Bureau,Hoovers,Diversity Careers(1)(2),The Artech Circle,NJTVOnline,The Business Forum Show, andSIA: Above the Crowd.
Connect with Artech through Social Media
Learn more about our company including the latest events at Artech, new job opportunities, jobseeker tips, and more. Follow us onFacebook,Google+,LinkedIn,Pinterest,Twitter, andYouTube.Estimated Salary: $20 to $28 per hour based on qualifications.
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