Mela Sciences Inc. Work Values

Daily Duties at Mela Sciences Inc.:

Analyzed Quality System documentation for completeness, inaccuracies, redundancies, and consistencies to ensure regulatory compliance. Ensured all change orders were implemented according to the change procedure by assigning numbers and tracking and reviewing requests in coordination with the initiator, Department Managers, and owners. Provided technical review for quality documentation, including engineering drawings, change requests, training records, Device History Records (DHR), calibration records, Design History Files (DHF), FDA correspondences, deviations, and Non-Conformance Records (NCR). Maintained the hard and electronic copies of the MelaFind External List of requirements and standards. Supervised and directed Document Control Administrator, whose responsibilities included tracking, distributing and maintaining controlled documentation.

What they like about Mela Sciences Inc.:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

medical device, document control, pharmaceutical, document control manager, FDA, CE Mark, audit, document analysis, edit, change request, Design History Files, Device Master Records, documentation, quality, regulatory, Excel, quality system, Microsoft Offiice

Skills

Manage document control for company quality system documentation, to ensure compliance with FDA and European Union laws and regulations. , Analyze Quality System documentation for completeness, inaccuracies, redundancies, and consistencies to ensure regulatory compliance., Provide technical review for quality documentation, including engineering drawings, change requests, training records, Device History Records (DHR), calibration records, Design History Files (DHF), FDA correspondences, deviations, and Non-Conformance Reco, Coordinate Change Order (CO) process document analysis, editing, and approval , Excellent proficiency in Microsoft Office., Quality and Regulatory Requirements: FDA Quality System Regulations (QSR), ISO 13485, ISO 9001, European Union Medical Device Directives (MDD), Excellent analytical and problem solving skills.

These are some of the questions we asked our climbers about their experiences with Mela Sciences Inc.: