QA Specialist - (US-PA-Malvern - 19355)

Minimum Education: Tech School
Job Type: Full Time
Jobcode: 334477
Email this job to yourself or to a friend

QA Specialist
Duties: Coordinates/manages Quality System Regulation activities for sanofi-aventis dermatology products and medical devices products, specifically related to design review activities to ensure compliance with established regulations and practices.
Tracking process for training documenation. Ensuring timely return of documentation by all trainees.
Responsible for managing design review preparation, meetings and documentation. • Leads the Design Panel Review activities for dermatology medical devices (related to phase 5 commercialization/launch), interfacing with cross functional team members, to facilitate meetings and documentation for Design Panel Review.
• Prepares and updates the medical device functional requirements, documentation required for reference and demonstration that all customer requirements have been met, for the Design History Files.
• Works closely with the International Marketing Manager in the planning, assessment and preparation for New Market Launches.
• Works closely with the Global Management Representative in US Q&C, in the planning, preparation and with the documentation requirements for New Market or New Indication Launches.
• Faciliate the collection of key documents from cross functional team members, including affiliates, required by the Quality System SOP’s and customer requirements.
• Schedules Design Review Meeting, authors and submits meeting minutes to Design History File Coordinator.

Skills: Must have QA experience, preferably on medical devices.
Must be able to plan meetings and coordinate documents.
• Must have excellent communication and interpersonal skills.
This position requires good project management experience, must be able to facilitate meetings and lead discussions with the design panel review members with the goal of making decisions to move forward on approval of design phase.

Education: • BS in the sciences or medical fields or equivalent • Minimum 5 years experience in medical device design and development or pharmaceutical drug development

If interested pls email your resume sonia@newagesys.com