Quality System Specialist - Raynham, MA
Do you have expierence as an Quality System Specialist ?! Check this position out!
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)
• 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
Full Time, Temp Position
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