Oct 12, 2021

Quality Manager for Medical Device Development

$80,000 - $125,000 yearly
  • VentriFlo Inc
  • Pelham, NH, USA
Full time Health Care Product Development Quality Regulatory

Job Description

Job Description

The Quality Manager role has primary responsibility for supporting and managing the Quality Management System assisting with development and implementation of standard operating procedures in compliance with applicable FDA, ISO-13485, CE, and other regulatory certification requirements as well as with internal policies and objectives.

Job Functions (Essential):

  • Collaboration with cross-functional leads to establish quality specifications for all products and processes
  • Ensure appropriate quality planning and procedures for new products, design changes and process modifications
  • Establish tools to monitor quality processes and prepare reports of findings on a regular periodic basis and present at management review meetings
  • Establish and implement appropriate methods such as design of experiments, sampling techniques and data analysis for products and processes
  • Perform supplier qualifications
  • Help resolve quality problems and product performance issues using sound engineering principles and problem-solving techniques including root cause and economic analyses
  • Ensure that inspection and approval of incoming materials and work-in-process is appropriate, in conformance with specifications and adequately documented

Required Education & Experience:

  • Bachelor's degree preferred
  • At least 7 years Medical Device industry experience
  • Minimum of 5 years Regulatory Affairs and/or Regulatory Operations experience
  • Knowledge of U.S. and international regulations including FDA, ISO, and cGMP guidance documents

Preferred Skills and Experience:

  • Experience with issue-tracking software, Jira (atlassian.com/software/jira)
  • Experience with eQMS software, Greenlight Guru (greenlight.guru)

Internal Job Number: 2-1

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