What are the responsibilities and job description for the Documentation Control Coordinator (Stratford, CT) position at CEDENT?
Job Overview
Under general supervision, assists the Directors of Quality and Engineering perform a range of activities to help drive coordinated release of records from the Engineering Change process. This coordination involves ensuring a variety records (e.g., including but not limited to Standard Operating Procedures, Work Instructions, Bills of Materials, Purchasing Specifications and Test Plans) involved with a proposed change are updated, released and trained on by appropriate personnel prior to the change being made effective.
Responsibilities and Duties
· Participate in regular Engineering Change Meetings
· Evaluates proposed Engineering Change order and collaborates with the Assigned Engineer to coordinate deliverables from cross functional teams including Quality, Marketing, Engineering and Production
· Review document records to ensure they are complete and meet Regulatory and Quality Management System requirements
· Uploads documentation to appropriate records within the QMS software for final Review and Approval
· Serves as a resource for training new Assigned Engineers in the process
· Manages the Engineering Change process template and submits revisions as necessary to ensure continuous improvement as matures
· Serves as a SME for Change records during Audits
Qualifications
· Bachelor’s Degree in Engineering or Life Science
· 3 years Quality Assurance/Control experience in manufacturing environment.
· Understanding of ISO 13485 implementation
· Proficiency using Microsoft Suite (Word, Excel, PowerPoint)
· Proficiency in using ERP (Netsuite) and Quality (Qualio) enterprise software.
· Proficiency in using SolidWorks engineering software.
· Excellent oral and written communication skills
· Highly detail-oriented
Under general supervision, assists the Directors of Quality and Engineering perform a range of activities to help drive coordinated release of records from the Engineering Change process. This coordination involves ensuring a variety records (e.g., including but not limited to Standard Operating Procedures, Work Instructions, Bills of Materials, Purchasing Specifications and Test Plans) involved with a proposed change are updated, released and trained on by appropriate personnel prior to the change being made effective.
Responsibilities and Duties
· Participate in regular Engineering Change Meetings
· Evaluates proposed Engineering Change order and collaborates with the Assigned Engineer to coordinate deliverables from cross functional teams including Quality, Marketing, Engineering and Production
· Review document records to ensure they are complete and meet Regulatory and Quality Management System requirements
· Uploads documentation to appropriate records within the QMS software for final Review and Approval
· Serves as a resource for training new Assigned Engineers in the process
· Manages the Engineering Change process template and submits revisions as necessary to ensure continuous improvement as matures
· Serves as a SME for Change records during Audits
Qualifications
· Bachelor’s Degree in Engineering or Life Science
· 3 years Quality Assurance/Control experience in manufacturing environment.
· Understanding of ISO 13485 implementation
· Proficiency using Microsoft Suite (Word, Excel, PowerPoint)
· Proficiency in using ERP (Netsuite) and Quality (Qualio) enterprise software.
· Proficiency in using SolidWorks engineering software.
· Excellent oral and written communication skills
· Highly detail-oriented
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