Jan 06, 2022

Design & Development Quality Manager

$90,000 - $120,000 yearly
  • HS Design Inc.
  • 906 Mount Kemble Avenue, Morristown, NJ, USA
Full time Engineering Product Development Quality R&D

Job Description

Reporting to the VP of Design & Development, the Quality Manager is responsible for maintaining the Quality Management System by updating and creating standard operating procedures, work instructions, and forms that comply with ISO-13485 and other standards. In addition, the Quality Manager will work with the R&D teams to create and approve quality and risk related specifications.

Duties & Responsibilities:

  • Drive key changes and continuous improvement in site Quality systems and procedures
  • Liaise with other Design and Development sites within SteriPack to develop best QA practices
  • Serve as the Quality engineer in programs, helping to create and/or review and sign quality related documents such as Design inputs, FMEAs, Hazard analysis, Trace Matrixes, Prints, Protocols, and Reports
  • Serve as the Quality Management Representative during quality audits
  • Respond to audit findings by creating and following through on action plans and CAPAs
  • Assist in the implementation of Greenlight Guru software for product development
  • Manage quality metrics and ensure adherence to quality objectives
  • Perform supplier qualifications
  • Manage calibration of testing equipment
  • Manage development team training records

Required Education & Experience:

  • Bachelor’s degree in Engineering or related fields
  • 7+ years of experience in Medical Device industry
  • 5+ years of relevant experience in Quality, Quality engineering, or Regulatory operations
  • Working knowledge of ISO 13485:2016 and ISO 14971
  • Strong analytical skills and timely decision-making ability

Preferred Skills

  • Working knowledge of eQMS software Greenlight Guru
  • Trained as lead auditor for 13485:2016
  • CAD software (Solidworks)
  • Minitab statistical software
  • Working Knowledge of 21CFR 210/211

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