Document Control Coordinator II

Document Control Coordinator II

In a team environment on production floor, warehouse, box room or office area perform a variety of tasks with established procedures which includes documentation and guidelines. Must be able to communicate clearly with co-workers both in speech and in writing.

The DCS will process Document Change Orders (DCO's). This activity includes maintaining documentation and data supporting product lines and company operations in accordance with applicable regulations (ISO/MDD, FDA, etc).

Your responsibilities will include:

• Works in Document Control for managing documents while ensuring quality, accuracy, and integrity of the hardcopies as well as electronic files.
• Comply with quality record retention, safeguard information, and retrieve the quality records more effectively.
• Executes routine DCO change packages (e.g., process redlines, proofread, make corrections, and document training). Assign part and document numbers.
• Provides guidance to other departments during the document change process.
• Maintains control of electronic and hard copy for SOPs, product drawings, labeling, artwork, process validation, manufacturing procedures, design control, marketing and educational material and test reports.
• Informs Vendors and Staff of document updates and provides controlled copies when applicable.
• Uses GDP (Good Documentation Practices) to correct records or assist others in correcting records.
• File, store, manage and track company documents for the Quality Management System.
• Performs scanning, filing, copying to maintain documents and obsolete inactive or older revision documents.
• Helps product development team maintain drawings, work orders, DCOs, etc.
• Perform administrative tasks as required.
• Releases DCOs, updates logs and lists.
• Reviews documentation for completeness.
• Files, organizes, archives, releases documentation both as hardcopy and electronic files.
• Consult with engineering, operations, and other cross functional teams for documentation requirements.
• Verifies completeness of the DCO requirements prior to release of documents into QMS.

Required qualifications:

• 1-2 Years with High School Diploma and/or
• 2 4 years Quality role in medical device or related industry

Preferred qualifications:

• BS/AS in Engineering or scientific discipline or equivalent document control experience

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer.