Mela Sciences Inc. Work Values

Daily Duties at Mela Sciences Inc.:

Managed the Design History File (DHF) and Device Master Records (DMR) in digital and hard copy formats. Maintained minutes from project, quality group, risk management, change request, and design review meetings.Prepared key documentation and information to support BSI and FDA audits, and participated in audit interviews. Created and managed and maintained appropriate top-level electronic directories, associated folders, subfolders, and files and established permission policies on a public server computer managed by QA/RA. Coordinated Change Order (CO) process document analysis, editing, and approval. managed document control for MELA’s quality system documentation, to ensure compliance with FDA and European Union laws and regulations.

What they like about Mela Sciences Inc.:

A hiring company that offers alternative approaches to pay, performance bonuses, and/or equity in the firm is very attractive to you. You're generally less interested in working for an organization offering only traditional, salary-based compensation, one with limited opportunity to acquire equity in the firm, or one that does not actively promote skill development. In addition, you are more likely to choose a company that offers a variety of internal career options, with defined career paths. You view the learning of new skills and development of your expertise as key to your career advancement. These aspects of an organization may become even more important to you as you progress in your field, and are especially critical if you change career or occupation.

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.: