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Quality System Specialist - Raynham, MA

Do you have expierence as an Quality System Specialist ?! Check this position out!

Hours: 8AM-5PM

PURPOSE: Provide support and supervision for the management and control of quality system documentation, labeling and the employee training program in compliance with notified body, FDA and ISO requirements.

3-6 MONTH TEMP ASSIGNMENT (MEDICAL LEAVE)

GENERAL RESPONSIBILITIES:

• Supervise labeling activities

• Support CAPA, Complaints, and Internal and External Audits, as required

• Manage controlled documents including organization of files/folders, control of distribution of documents, retrieval of obsolete revisions

o Create and maintain Standard Operating Procedures (SOP) and General Procedures (GP) relating to Document Control, Control of Records, Employee Training, and other areas as required.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Strong organizational and project management skills

• Proficiency with Microsoft Office Suite, Adobe Acrobat, Illustrator and InDesign, Bartender, SolidWorks and Product Data Management (PDM) and/or other Document Control systems.

EDUCATION AND EXPERIENCE:

• Minimum of 5 years’ experience with implementation of Documentation Control preferably within the medical device industry.

• Working knowledge of ISO 13485 and FDA 21CFR Part 820, MDD and CMDR

 


Keywords: Quality System Specialist, Documentation, Document Control, Engineering Change Systems

Job ID:
109-184911

Location:
Raynham, MA

Job Type:
Full Time, Temp Position

Posted:
7/18/2018

Contact: michelle.mercier@advantageresourcing.com

Apply for this Position

Quality System Specialist

City, State or Zip Code: Raynham, MA

Position Type: Full Time, Temp Position

Date Posted: 7/18/2018