46422-4738 - Configuration Management Engineer

Location: Portsmouth
Posted on: November 2, 2024

Job Description:

Requisition # : 46422-4738
Positions : 2
Start Date : 11/17/2014
End Date : 5/18/2015
Over Time Allowed : Yes
Interview Type : Interview
Travel : No Travel Required
Environment : Professional
Schedule : Typical 8 Hour/Day
Dress Code : Business Casual
Work Location : Portsmouth, NH 03801
Labor Category : Engineering
Job Family : Hardware/Software
Job Title : Configuration Management Engineer

*Job Duties : Participates in Design and Code Reviews

Required:
*Education Level: Undergraduate Degree
*Supply Chain Management Packages: SAP

Request Notes :
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, 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 policies, practices and procedures to ensure that Food and Drug Administration and ISO/MDD regulations, 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.

If you are interested in this opportunity and you qualify please complete the following and send back with your updated resume.
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Requirement #: 46422-4738
Your resume in Word format along with your salary requirements to rsanderson@keystonecs.com

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