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Finish Line Staffing Services
Published
November 18, 2021
Location
Burlington, MA
Category
Default  
Job Type

Description

Our client, a biotech pioneer in organ transplant technologies and therapies, is seeking an experienced Senior Quality Engineer.

Responsibilities:

  • Maintain and improve Quality Management System to support Class III medical devices.
  • Coordinate quality data collection, analyses and reporting for Management Reviews and Post Market Surveillance
  • Manage the Corrective and Preventive Action (CAPA) system
  • Lead the Quality Audit system by managing the audit schedule and participating in and leading internal audits. Supports 3rd party audits (ISO, FDA, etc.)
  • Support Design, Complaint, NCMR investigation project as needed
  • Identify product and process improvements; leads and supports their implementation
  • Ability to travel (approximately 5%)
  • Perform other tasks and duties as required

Experience:

  • Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations.
  • Demonstrated expertise in one or more of the quality processes required: CAPA, Audit, Complaint, Design Control.
  • Experience in Post Market Surveillance or Design Control desired
  • Knowledge of EtO or Gamma sterilization of disposable medical devices desired
  • Ability to create and work with databases, queries and reports is a plus
  • Experience with electronic QMS software system is a plus
  • Highly detailed oriented with strong organization and prioritization skills
  • Ability to manage multiple projects and changing priorities
  • Must be purposeful and exhibit a sense of urgency
  • Communicate ideas and information clearly, effectively, and concisely
  • Detail oriented with strong organization and prioritization skills
  • Capable of managing multiple projects and changing priorities
  • Purposeful and exhibit a sense of urgency

Education:

  • BS in Science, Engineering, or technical discipline with at least 5 years’ experience in Quality, Engineering, Design in the medical device, pharmaceutical industry, or equivalent combination of education and experience
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