Three Point Solutions, Inc. Hiring for Engineering Document Control Coordinator (100% remote) at Remote Full Time

Job title : Coordinator, Document Control I (Remote)

Client : Medical Device Manufacturing Company

Duration : 08 months

Description:

Qualifications:

• High school diploma or equivalent is required.
• 0 to 3 years related Document Control experience in a manufacturing environment is required.
• Experience in a Quality control regulated industry preferred.
• Familiar with the Engineering Release and Change Control process.
• Familiar with Bills of Materials and Routers within the manufacturing environment.
• General office skills (data entry, scanning documents, filing, etc.)
• Proficient User and Knowledge of Microsoft Office (Word, Excel, Outlook).
• Basic computer skills as required to perform job duties
• Must be detail-oriented
• Strong Organizational skills
• Quality and Customer oriented.
• Must possess a high degree of personal organization and excellent communication skills, both written and verbal.
• Excellent interpersonal and teamwork skills
• Work independently and part of a team
• Knowledge of ISO13485/FDA quality system regulations (preferred)
• Ability to work effectively on an independent basis with multiple projects simultaneously.
• Ability to perform required duties with minimum supervision.

Responsibilities:

• Service Provider will be responsible for searching electronic sources such as ERP systems, spreadsheets, and databases for the provision of information in support of OSTA’s EU MDR compliance initiative.
• This position supports OSTA’s European Medical Device Regulation (EU MDR) compliance initiative.
• The Service Provider will provide hands-on support for the initiation and processing of change management of Labeling Content and various other technical documentation related to the implementation of Instructions for Use and Labels.
• Secondary Responsibilities as of member of the Documentation Control team, is responsible for processing Engineering Change Orders and coordinate with other business functions (Mfg.Eng.,R/D Eng., Supply Chain, Quality, etc.) and Olympus sites to ensure efficient and accurate release of product or process changes that impact the Quality Management System through
• Review (inspect) Change Order types (ECO/CO/DEV/IMC) for content, accuracy, and completeness.
• Monitor and promote change management workflows.
• Support all release and change activity for new and existing products, plus other controlled documents.
• Perform item entry into PLM & ERP systems as required (Including New Catalog & Item numbers, Bills of Materials, Routers, Engineering Changes and Deviations).
• Coordinate the disposition and inventory impact of changes with teams within site (Engineering, Supply Chain, Quality, Finance, etc.) or across Olympus, to ensure accurate, complete and efficient change order processing.
• Communicate with others within Document Control and Olympus sites for coordination of Change Orders as required.
• Communicate with Quality Management on any and all issues/problems that may have impact to Olympus, manufacturing site and department goals.
• Update procedure/specification type word documents as required.
• Ensuring document attachment/links are present and accurate within PLM system which reflect the change in accordance with the Quality Management System.
• Create, maintain and control the master documentation files.
• Support Engineering and general change management users by answering questions and resolving documentation issues.
• Scan and file documents as required.
• Monitor the status of employee training to ensure that controlled documents are only released when applicable training requirements are met.
• Participate in Document Control team meetings and complete assigned action items.
• Maintain acceptable standards for attendance and work overtime as needed.
• All other essential duties as directed

Job Types: Full-time, Contract

Salary: $38.00 – $42.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• High school or equivalent (Preferred)

Experience:

• Document management: 1 year (Required)
• Engineering Documentation: 1 year (Required)
• EU MDR: 1 year (Required)
• ISO 13485: 1 year (Required)

Work Location: Remote