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Sr Quality Engineer

Wilmington, MA 01810

Posted: 09/29/2021 Industry: Engineering and Technical Job Number: 13322

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Hiring Organization: Connexion Systems & Engineering

Senior Quality Engineer - BH 13322

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.

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

BH13322

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