|
|
|
|
Company:
|
Makro Technologies Inc |
|
Job Title:
|
QA Specialist |
|
Job Category:
|
Information Technology |
|
Job description:
|
Duties:
Coordinates/manages Quality System Regulation activities for Client dermatology drug products and medical devices, specifically related to design review activities to ensure compliance with established regulations and practices.
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, international teams, 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.
Facilitates 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.
Support updates/revision to SOP's
Support training activities, tracking for training documentation. Ensuring timely return of documentation by all trainees.
Support Post Market Clinical Supplies activities, audit follow-up, deviation report reviews and change control.
Skills:
Must have QA experience with medical devices, drug/device combination or drug products.
Must be able to plan meetings and coordinate documents, be very organized.
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 phases.
Education:
BS in the sciences or medical fields or equivalent
Minimum 5 years experience in medical device design and development or pharmaceutical drug development |
|
Skills:
|
medical devices, drug/device combination or drug products, medical device design and development or pharmaceutical drug development |
|
Language requirements:
|
|
|
Employment type:
|
|
|
Salary Range:
|
Unspecified |
| |
| Other Information |
 |
|
| |
|
Degree:
|
Bachelors |
|
Experience (year):
|
0 |
|
Job Location:
|
Malvern, PA - USA |
|
Post Date:
|
02/23/2009 |
| |
| Contact Information |
|
|
| |
|
Company:
|
Makro Technologies Inc |
|
Contact Name:
|
Sarath |
|
Contact Email:
|
sarath.nanda@makrotech.com |
|
Contact Phone:
|
973-481-0100 Ext: 3016 |
| |
| Apply Online |
|
|
| |
|
|
|
