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Quality Specialist

West Boylston, MA 01583

Posted: 05/25/2023 Employment Type: Contract To Hire Job Number: 40242 Pay Rate: 24.00

Job Description

  • Responsibilities:
  • A Quality Specialist will maintain a specialty that will focus on primary responsibilities such as system administration, inspection processing and document control. Each Quality Specialist will also cross train in other areas of the quality organization to strengthen the department and company.
  • Responsible for following Quality Management System, cGMP’s and ISO13485 requirement
  • Documentation Control:
  • Understands and follows good documentation practices in a cGMP and ISO 13485 environment.
  • Organize and review Device History Records (DHR’s) at the completion of the manufacturing cycle and ensure all signatures and data are present.
  • Scan Device History Records (DHR’s) to save electronically and upload to customer FTP sites.
  • Assists with maintaining the Quality System Documentation Control System including the Master list.
  • Assist the Quality management with the creation, updating, and processing of new and existing procedures, work instructions, and all other Quality department documentation.

  • Assists in the development and maintains associate training curriculum, which consists of documentation, training records, training matrix and materials.
  • Assists with maintaining project specific work instruction control forms.
  • Assists with preparing and deliver curriculum as necessary to support training needs.
  • Assists in providing Training Plan / Job Description for employees.
  • Files training logs within Omnify upon completion of training.
  • Creates training within Omnify as required.
  • Coordinates training classes when appropriate.
  • Must be proficient in the use of the Omnify Training module.
    • Material Review Board
      • Assist the Material Review Board manager in the initial processing of non-conforming material into the electronic systems.
      • Organize materials to ensure the preservation of the materials
      • Able to effectively communicate issues to suppliers, both verbally and through email.
      • Prepare materials to be returned to suppliers.
    • Production Quality
      • Assists with gathering quality data for metrics and distribution of production metrics.
        • Able to assist Receiving Incoming Inspection by processing incoming material, that require incoming inspection, in the electronic systems.
        • Identifies and reports any product or documentation quality problems or discrepancies.
        • Ensures products are moved to proper locations as appropriate.
        • Documents any non-conformances and ensures all product non-conformance paperwork is complete and is included in the work order package.
        • Maintains proper control of device traceability materials and non-conforming material.
        • Maintains work area and equipment in a clean and orderly condition and follows prescribed safety regulations.
        • Perform all Quality Department administrative functions as required.
        • Assist with all FDA, Notified body, Internal and/or customer audit related activities; as needed.
        • Coordinate with Quality management on quality problems relating to the product, process and Quality System.
        • Performs other activities as directed.
      • Essential Requirements:
        • Positive attitude, self-motivator and tenacious follow up.
        • Attention to details and superior organizational skills.
        • Superior customer service attitude.
        • Demonstrated skills in administrative roles.
        • High School Diploma or equivalent. Further technical training or education preferred.
        • Working knowledge of cGMP, QSR, ISO, SOP’s, work rules and safety guidelines preferred.
        • 2+ years office experience, preferably in a medical device manufacturing organization.
        • Advanced computer skills in such areas as Excel, Word, PowerPoint, Project, Visio, ERP, and Database Management preferred.
        • Effective communication skills, both written and verbal.
        • Must be able to read, write, and fully comprehend English.
        • Excellent teamwork, communication, and interpersonal skills.
        • A demonstrated commitment to company values.
      • Physical requirements
        • Excellent manual dexterity and eye/hand coordination.
        • Standing for prolonged periods of time.
        • Sitting for prolonged periods of time.
        • Ability to lift up to 30 lbs.

Meet Your Recruiter

Rebecca Barry
Recruiting Specialist

Rebecca is a Recruiting Specialist with the Engineering Division of The Panther Group. Rebecca's niche is working to place candidates with Panther's manufacturing clients.   She brings passion and knowledge of Manufacturing and Production to each of the candidates she engages with!  


Fun Fact:  Rebecca is a huge country music fan and loves Texas but hates the heat! 

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