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Quality Engineer

Connexion Systems & Engineering, Inc.
Lawrence, MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description



Senior Quality Engineer

105-115k + bonus/equity
Full Time
Andover, MA, US

ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:

·           Maintains and improves Quality Management System to support Class III medical devices. 

·           Coordinate quality data collection, analyses and reporting for Management Reviews and Post Market Surveillance

·           Manages the Corrective and Preventive Action (CAPA) system

·           Leads 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

·           Identifies product and process improvements; leads and supports their implementation

·           Some travel may be required (approximately 5%)

·           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
  • Experience in EtO or Gamma sterilization of disposable medical devices desired
  • Experience creating and working with databases, queries and reports is a plus
  • Experience with QMS software system is a plus
  • Highly detailed oriented with strong organization and prioritization skills
  • Must possess the ability to handle multiple projects and changing priorities
  • Must be results-driven and exhibit a sense of urgency
  • Ability to communicate ideas and information clearly, effectively and concisely
  • Highly detailed oriented with strong organization and prioritization skills
  • Must possess the ability to handle multiple projects and changing priorities
  • Must be results-driven 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

 

Company Description
Connexion is a full-service, award winning staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement, and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

Connexion Systems & Engineering, Inc.

Connexion is a full-service, award winning staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement, and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

Address

Lawrence, MA
USA

Industry

Manufacturing

Website

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