Document Control Specialist

Elevaris Medical Devices • Wilmington, MA

8h

About The Position

This position is responsible for supporting quality documentation activities. Responsibilities include filing, copying, and scanning quality documentation using an effective and efficient document control system to ensure accuracy, completeness, and immediate availability of critical records. The role also includes managing document close-out activities and maintaining organized, compliant files in accordance with quality system requirements.

Requirements

• High School Diploma or equivalent
• 1-2 years relevant experience in a document control role

Nice To Haves

• Associate or bachelor’s degree preferred
• Experience working in a medical device company
• Excellent organizational, verbal, written communication and problem-solving skills
• Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive and collaborative manner
• Ability to work in a fast-paced environment and to meet tight deadlines
• Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
• Ability to multi-task with strong attention to detail
• Proficient in MS Office Suite
• Knowledge of ERP/MRP systems, helpful

Responsibilities

• Review and ensure accuracy of Quality documentation
• MasterControl (eQMS) tasks; Create Courses and Exams for new documents, revise Exams as needed and assists with the review and release of Engineering Change Orders as received
• Monitor status of in-process document changes to ensure timely approvals
• DocStar proficiency to provide daily scanning and filing of Quality documentation such as daily shipping packets, Receiving Reports, Inspection Data, Sorting Records, Complaints, NCR’s, SCARs, CAPA’s, RA’s, and as necessary other related documentation
• Update, reconcile and maintain the DHR files in both QA and Operations, including closure of files
• Provide monthly Document Control Metrics report
• Provide monthly On-Time Training Metrics
• Process daily Training reports to ensure employee-assigned training tasks are completed in a timely manner
• Prepares Quality & Operations documents for off-site storage, including scheduling pickup via the Iron Mountain website
• Supports Quality Audits and QA projects as necessary
• Supports QC on an as-needed basis in the generation of Certificates of Compliance for product shipments to customer
• Prepare and/or generate QA Inspection documentation
• Suggest & support continuous improvement
• Cross-functional project collaboration, as needed
• Upholds and role-models company Values of Integrity, Invested, Inclusion and Ingenuity
• Other duties as assigned by management

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED